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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs AdComm

Meeting Date: 1/22/15-1/22/15

Meeting Details:

The committee will discuss new drug applications (NDAs) 207-500 and 207-501, isavuconazonium sulfate capsules and isavuconazonium sulfate for injection, sponsored by Astellas Pharma Global Development, Inc., respectively for the proposed indications of treatment of invasive aspergillosis and mucormycosis.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs AdComm - Cerexa Inc.

Meeting Date: 12/5/14-12/5/14

Meeting Details:

The committee will discuss new drug application (NDA) 206494 for ceftazidime-avibactam for injection, submitted by Cerexa Inc., for the proposed indications of: Complicated Intra-abdominal Infections, Complicated Urinary Tract Infections, including Acute Pyelonephritis and Limited Use Indication: Aerobic Gram-negative Infections with Limited Treatment Options.

 

       
Location: The Marriott Inn and Conference Center 3501 University Blvd. East, Hyattsville, Maryland 20783 Related News Links: Not Available
Time: 8:00AM-4:30AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs AdComm

Meeting Date: 12/4/14-12/4/14

Meeting Details:

The committee will discuss issues related to clinical development programs and clinical trial designs for antibacterial products for the treatment of patients with serious bacterial infections for which there are limited or no therapeutic options.

 

       
Location: The Marriott Inn and Conference Center 3501 University Blvd. East, Hyattsville, Maryland 20783 Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs Advisory Committee

Meeting Date: 3/31/14-3/31/14

Meeting Details:

During the morning session, the committee will discuss new drug applications (NDAs) 205-435 and 205-436, tedizolid phosphate tablets and tedizolid phosphate injection, submitted by Trius Therapeutics, respectively, for the proposed indication of treatment of acute bacterial skin and skin structure infections. During the afternoon session, the committee will discuss NDA 021-883, dalbavancin hydrochloride for intravenous injection, submitted by Durata Therapeutics International B.V., for the proposed indication of treatment of acute bacterial skin and skin structure infections.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs AdComm

Meeting Date: 10/17/13-10/18/13

Meeting Details:

The purpose of the meeting on October 17, 2013, is to discuss susceptibility interpretive criteria for systemic antibacterial drugs and for dosing recommendations in product labeling. We will seek input on the role of pharmacokinetic data in setting susceptibility interpretive criteria. We will also discuss revising dosing recommendations in product labeling based on pharmacokinetic data and clinical safety and efficacy data. On October 18, 2013, the committee will discuss the safety and effectiveness of new drug application (NDA) 204684, miltefosine capsules, submitted by Paladin Therapeutics, Inc., for the proposed indication of treatment of patients with visceral (involving internal organs), mucosal (involving areas such as inside the mouth and nose), and cutaneous (involving the skin) leishmaniasis, an infection caused by a parasite.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs AdComm

Meeting Date: 11/29/12-11/29/12

Meeting Details:

The committee will discuss new drug application (NDA) 22407, VIBATIV (telavancin hydrochloride) sterile powder for injection, submitted by Theravance, Inc., for the requested indication of nosocomial pneumonia (pneumonia contracted by hospitalized patients), including ventilator-associated pneumonia, caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae (penicillin susceptible strains).

 

       
Location: DoubleTree by Hilton Hotel Washington DC–Silver Spring Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs AdComm

Meeting Date: 11/28/12-11/28/12

Meeting Details:

On November 28, 2012, the committee will discuss the safety and effectiveness of new drug application (NDA) 204384, bedaquiline tablets, submitted by Janssen Therapeutics, Division of Janssen Products, LP. The proposed indication (use) for this product is for the treatment of patients with multi-drug resistant pulmonary tuberculosis.

 

       
Location: DoubleTree by Hilton Hotel Washington DC/Silver Spring Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs AdComm

Meeting Date: 11/2/12-11/2/12

Meeting Details:

The committee will discuss biologics license application (BLA) 125346, raxibacumab injection, a humanized monoclonal antibody against protective antigen of Bacillis anthracis, by Human Genome Sciences, Inc., for the proposed indication of treatment of inhalational anthrax.

 

       
Location: DoubleTree by Hilton Hotel Washington DC-Silver Spring Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs Advisory

Meeting Date: 9/5/12-9/5/12

Meeting Details:

The committee will discuss new drug application (NDA) 201688, tobramycin inhalation powder, application submitted by Novartis Pharmaceuticals Corporation, and the requested indication of management of cystic fibrosis patients infected with the bacterium Pseudomonas aeruginosa.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs AdComm

Meeting Date: 4/3/12-4/4/12

Meeting Details:

On April 3, 2012, during the morning session, the committee will discuss the development of an animal model of pneumonic plague (plague infection with extensive lung involvement) in African Green Monkeys and provide advice concerning the relevance of the animal model to pneumonic plague in humans resulting from exposure to Yersinia pestis (the bacteria that causes plague) in a bioterrorism event. During the afternoon session, the committee will discuss the data provided to support the safety and efficacy of ciprofloxacin for the treatment of pneumonic plague in humans. The National Institute of Allergy and Infectious Diseases (NIAID) has submitted efficacy data for ciprofloxacin, based on treatment in an animal model of plague. Safety and other supportive information is derived from clinical studies and post-marketing experience in humans. On April 4, 2012, the committee will discuss the data provided to support the safety and efficacy of levofloxacin for the treatment of pneumonic plague in humans. Johnson and Johnson Pharmaceutical Research and Development, LLC (on behalf of Janssen Pharmaceuticals, Inc.), has submitted efficacy supplements for LEVAQUIN (levofloxacin) tablets, injection, and oral solution (NDA 20-634, NDA 20-635, and NDA 21-721, respectively) for treatment of pneumonic plague. Efficacy data for levofloxacin is based on treatment in an animal model of plague. Safety and other supportive information is derived from clinical studies and postmarketing experience in humans.

 

       
Location: DoubleTree by Hilton Hotel Washington DC/Silver Spring Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Anti-Infective & Nonprescription Drugs AdComm

Meeting Date: 4/2/12-4/2/12

Meeting Details:

The committees will provide advice on types of consumer studies needed to assess proper use of a MedKit containing doxycycline to be taken in the event of anthrax exposure. Issues such as the feasibility of an FDAapproved MedKit as a public health strategy, the role of personal MedKits, home stockpiling, and interfaces of home readiness with public health systems, will be raised in the course of the discussions. The Biomedical Advanced Research and Development Authority will propose a possible plan for a step-wise development program for MedKits containing oral doxycycline hyclate.

 

       
Location: DoubleTree by Hilton Hotel Washington DC/Silver Spring Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs Advisory Committee Meeting

Meeting Date: 11/3/11-11/4/11

Meeting Details:

On November 3, the committee will discuss clinical trial design issues for the development of antibacterials for the treatment of Community-Acquired Bacterial Pneumonia (CABP) and the draft document entitled "Guidance for Industry, Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment", published March 2009 (see FDA Web site: Clinical/Antimicrobial Guidances1). On November 4, the committee will discuss clinical trial design issues in the development of antibacterials for the treatment of Hospital-Acquired Bacterial Pneumonia (HABP), including Ventilator-Associated Bacterial Pneumonia (VABP) and the draft document entitled "Guidance for Industry, Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment", published November 2010 (see FDA Web site: Clinical/Antimicrobial Guidances1).

 

       
Location: Hilton Washington DC/Silver Spring The Ballrooms Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs AdComm

Meeting Date: 4/5/11-4/5/11

Meeting Details:

On April 5, 2011, the committee will discuss new drug application (NDA) 20-1699, for FIDAXOMICIN tablets, submitted by Optimer Pharmaceuticals, Inc., for the requested indication of treatment of adults with Clostridium difficile infection (CDI), also known asClostridium difficile-associated diarrhea (CDAD), and prevention of recurrences.

 

       
Location: Hilton Washington DC/Silver Spring Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs AdComm

Meeting Date: 9/7/10-9/7/10

Meeting Details:

On September 7, 2010, the committee will discuss new drug application (NDA) 200327, for ceftaroline fosamil for injection, suOn September 7, 2010, the committee will discuss new drug application (NDA) 200327, for ceftaroline fosamil for injection, submitted by Cerexa, Inc., and the requested indications of: (1) Treatment of adults with community acquired bacterial pneumonia (CABP); and (2) complicated skin and skin structure infections (cSSSI). The morning session will be devoted to discussing the CABP indication, and the afternoon session to discussing the cSSSI indication.bmitted by Cerexa, Inc., and the requested indications of: (1) Treatment of adults with community acquired bacterial pneumonia (CABP); and (2) complicated skin and skin structure infections (cSSSI). The morning session will be devoted to discussing the CABP indication, and the afternoon session to discussing the cSSSI indication.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs AdComm

Meeting Date: 4/29/10-4/29/10

Meeting Details:

On April 29, 2010, the committee will discuss the efficacy and safety of new drug application (NDA) 21242, artesunate rectal suppositories, submitted by the World Health Organization, for the proposed use as a single dose for the initial treatment of patients with acute malaria who cannot take medication by mouth and for whom injectable treatment is not available.

 

       
Location: Hilton Silver Spring, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs AdComm

Meeting Date: 12/9/09-12/10/09

Meeting Details:

On December 9, 2009, the committee will discuss endpoints and other clinical trial design issues in the development of antibacterial products for the treatment of community-acquired bacterial pneumonia. On December 10, the committee will discuss new drug application (NDA) 050-814, inhaled aztreonam, Gilead Sciences, Inc., for the proposed indication of improvement of respiratory symptoms and pulmonary function in cystic fibrosis patients with Pseudomonas aeruginosa, a bacterial infection.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs AdComm

Meeting Date: 10/27/09-10/27/09

Meeting Details:

On October 27, 2009, the committee will discuss Biologic License Application (BLA) 125349, for raxibacumab injection, manufactured by Human Genome Sciences, Inc., proposed for the treatment of inhalational anthrax disease.

 

       
Location: Hilton Silver Spring MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs AdComm

Meeting Date: 10/26/09-10/26/09

Meeting Details:

The committee will discuss updating susceptibility test information in systemic antibacterial drug product labeling.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs Advisory Committee

Meeting Date: 6/2/09-6/3/09

Meeting Details:

On June 2 - The committee will discuss new drug application (NDA) 22398, cethromycin oral tablets, sponsored by Advanced Life Sciences, for the proposed indication of outpatient treatment of adults with mild to moderate community-acquired pneumonia. On June 3 - The committee will discuss issues related to the development of drugs for the treatment of tuberculosis, including drug resistant tuberculosis. Areas of discussion include diagnosis, treatment duration, study design (such as endpoints and duration of followup) and safety issues.

 

       
Location: Hilton Silver Spring MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs Advisory Committee

Meeting Date: 12/3/08-12/3/08

Meeting Details:

The committee will discuss new drug application (NDA) 22-268, artemether 20 milligrams (mg)/lumefantrine 120 mg, sponsored by Novartis Pharmaceuticals Corp., for the proposed indication of treatment of acute, uncomplicated malaria infection due to Plasmodium falciparum or mixed infections including P. falciparum.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs Advisory Committee

Meeting Date: 11/18/08-11/20/08

Meeting Details:

On November 18, 2008, the committee will discuss the justification of the non-inferiority margin for complicated skin and skin structure infections. On November 19, 2008, the committee will discuss: (1) New drug application (NDA) 022110, telavancin powder for reconstitution and intravenous administration, Theravance, Inc., proposed for the treatment of complicated skin and skin structure infection, and (2) NDA 022153, oritavancin, Targanta Therapeutics Corp., proposed for the treatment of complicated skin and skin structure infection. On November 20, 2008, the committee will discuss NDA 022269, iclaprim, Arpida AG, proposed for the treatment of complicated skin and skin structure infection.

 

       
Location: Holiday Inn/College Park College Park, MD. Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs AdComm

Meeting Date: 7/16/08-7/16/08

Meeting Details:

The committee will discuss new drug application (NDA) 022–171, doripenem powder for reconstitution and intravenous administration, Johnson and Johnson Pharmaceutical Research and Development, LLC, proposed for the treatment of nosocomial pneumonia, including ventilator-associated pneumonia.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs AdComm

Meeting Date: 4/1/08-4/2/08

Meeting Details:

On both days, the committee will discuss product development and clinical trial design for both mild/moderate and moderate/severe community acquired pneumonia (CAP). A primary objective for committee deliberations is to discuss issues relating to the identification of an appropriate noninferiority margin for active controlled trials.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCancelled: Anti-Infective Drugs AdComm

Meeting Date: 2/27/08-2/28/08

Meeting Details:

On February 27, 2008, the committee will discuss new drug application (NDA) 022-110, telavancin powder for reconstitution and intravenous administration, Theravance, Inc., proposed for the treatment of complicated skin and skin structure infection. On February 28, 2008, the committee will discuss NDA 022-132, ceftobiprole medocaril (500 milligrams), lyophilized powder for reconstitution and intravenous administration, Johnson and Johnson Pharmaceutical Research and Development, LLC, proposed for the treatment of complicated skin and skin structure infection.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Anti-Infective/Pediatric AdComm

Meeting Date: 4/12/07-4/12/07

Meeting Details:

The committee will discuss clinical trial designs for products that seek indications for the prevention and/or treatment of disease caused by Shiga toxin-producing bacteria. FDA intends to make background material available to the public no later than 1 business day before the meeting.

 

       
Location: TBA Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs AdComm

Meeting Date: 9/11/06-9/12/06

Meeting Details:

On September 11, 2006, the committee will discuss new drug applications (NDAs) 21-931, garenoxacin mesylate tablets, 400 milligrams (mg) and 600 mg, and NDA 21-932, intravenous garenoxacin mesylate, 400 mg (200 milliliters (mL) of 2 mg/mL) and 600 mg (300 mL of 2 mg/mL), proposed trade name GENINAX, submitted by Schering Corp., for the proposed treatment indications of acute bacterial exacerbation of chronic bronchitis, acute bacterial sinusitis, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and complicated intra-abdominal infections. On September 12, 2006, the committee will discuss supplemental new drug application (sNDA) 21-158/S-006, Factive (gemifloxacin mesylate) Tablets, submitted by Oscient Pharmaceuticals Corp., for the proposed treatment of acute bacterial sinusitis.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs AdComm - Cubicin by Cubist

Meeting Date: 3/6/06-3/6/06

Meeting Details:

The committee will discuss new drug application (NDA) 21-572/S-008, Cubicin (daptomycin for injection 500 mg/vial), Sponsor Cubist Pharmaceuticals, for the proposed indication of the treatment of staphylococcus aureus bacteremia, including those with known or suspected endocarditis caused by methicillin-susceptible and methicillin-resistant strains.

 

       
Location: FDA meeting room Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Subcommittee of the Anti-Infective Drugs Advisory Committee

Meeting Date: 6/9/04-6/9/04

Meeting Details:

The subcommittee will meet between 8 a.m. and 1:30 p.m., and the agency will report to the committee on adverse event reporting as mandated in section 17 of the Best Pharmaceuticals for Children Act. The products to be discussed during this portion of the meeting include HYCAMTIN (topotecan), TEMODAR (temozolomide), EFFEXOR (venlafaxine), MONOPRIL (fosinopril), ALLEGRA (fexofenadine), DURAGESIC (fentanyl), CILOXAN (ciprofloxacin), and VIGAMOX (moxifloxacin). Following this, from approximately 1:30 p.m. to 3:30 p.m., the agency will provide an update on neonatal withdrawal syndrome and congenital eye malformations reported in infants whose mothers used selective serotonin reuptake inhibitors (SSRIs) during pregnancy. From approximately 3:30 p.m. to 4 p.m., the agency will provide an overview of the Pediatric Research Equity Act, which was signed into law on December 3, 2003. From 4 p.m. to 4:30 p.m., there will be an overview of the Institute of Medicine report entitled "Ethical Conduct in Pediatric Clinical Trials." Finally, from 4:30 p.m. to 4:45 p.m., the agency will provide an update on the subpart D, institutional review board referral process.

 

       
Location: Rockville, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting Options*** Cancelled *** - BMS - Anti-Infective AdComm

Meeting Date: 5/10/04-5/11/04

Meeting Details:

On May 10, 2004 the committee will discuss NDA 21-678 (gatifloxacin) for oral suspension Bristol-Myers Squibb’s studied in the treatment of for recurrent bacteria otitis media and treatment failure of acute otitis media in pediatric patients. On May 11, 2004 the committee will discuss the use of microbiologic endpoints as surrogate markers for clinical efficacy in clinical trials designed to demonstrate the safety and efficacy of healthcare anticeptic drug products.

 

       
Location: HOL - GB Related News Links: Not Available
Time: 8:30AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Subcommittee of the Anti-Infective Drugs AdComm

Meeting Date: 2/3/04-2/4/04

Meeting Details:

On February 3, 2004, the subcommittee will meet between 9 a.m. and 10:15 a.m., and the agency will report to the subcommittee on Adverse Event Reporting as mandated in Section 17 of the Best Pharmaceuticals for Children Act (BPCA). The products to be reported during this portion of the meeting include: Paxil (paroxetine), Celexa (citalopram), Pravachol (pravastatin), and Navelbine (vinorelbine). Following this, from approximately 10:30 a.m. to 4:45 p.m., the subcommittee will discuss the use of imaging drugs in conjunction with cardiac imaging procedures in the pediatric population. On February 4, 2004, the subcommittee will meet between 8 a.m. and 12 noon to continue the discussion on the use of imaging drugs in conjunction with cardiac imaging procedures in the pediatric population.

 

       
Location: FDA Rockville, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic and Pediatric / Anti-Infective AdComm

Meeting Date: 2/2/04-2/2/04

Meeting Details:

The committee will discuss reports of the occurrence of suicidality (both suicidal ideation and suicide attempts) in clinical trials for various antidepressant drugs in pediatric patients with major depressive disorder.

 

       
Location: HOL - Beth Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Anti-Infective Subcommittee

Meeting Date: 10/29/03-10/30/03

Meeting Details:

On October 29th, the committee will discuss the risks of hypothalamic pituitary adrenal axis suppression in children who are being treated a topic dermatitis. The agency will report to the subcommittee on adverse advent reporting as mandadted by the Best Pharmaceuticals for children act. The products to be discuss will be Accupril by Pfizer; Cozaar by Merck; Nolvadex by AstraZeneca, Busulfex Orphan Medical, Serzone by Abbott and Zyrtec by Pfizer. On the 30th, the subcommittew will discuss how to approach long term monitoring for cancer occurence in patients treated for a topic dermatitis or topical immunosuppressants.

 

       
Location: Hilton - GB Related News Links: Not Available
Time: 8:30AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs Advisory Committee

Meeting Date: 10/28/03-10/29/03

Meeting Details:

On October 28, the committee will be closed from 8:00am - noon. From 1:00pm - 5:30pm the committee will discuss clinical trial desgin issues for demonstrating the safety and efficacy of anti-microbials in the treatment of diabetic foot infections. On October 29, the committee will discuss the clinical trial design issues for demonstration the dafety and efficacy of anti-microbials in acute sinusitis.

 

       
Location: HOL - GB Related News Links: Not Available
Time: 1:00PM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Subcommittee

Meeting Date: 6/11/03-6/12/03

Meeting Details:

On June 11, 2003, the subcommittee will discuss the current epidemiology and therapeutic interventions relevant to hyperbilirubinemia in the term and near-term newborn. On June 12, 2003, the subcommittee will begin with a closed session between 8 a.m. and 3 p.m. Following this, there will be an open subcommittee meeting from approximately 3:15 p.m. to 5 p.m., where the agency will report to the subcommittee on Adverse Event Reporting as mandated in Section 17 of the Best Pharmaceuticals for Children Act. The products to be discussed during this portion of the meeting include Zoloftâ (sertraline) Pfizer Inc., and Ditropanâ (oxybutynin) Alza Corp., with an interim update to be provided on Lipitorâ (atorvastatin) Pfizer Inc., and Zocorâ (simvastatin) Merck & Co. Inc.

 

       
Location: HOL - GB Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs Advisory Committee

Meeting Date: 3/4/03-3/5/03

Meeting Details:

On March 4, the committee will discuss NDA 21158 Factive tablets for the treatment of community acquired pneumonia & acute bacteria exasterbastion of chronic bronchitis. On March 5, the committee will discuss the formation of the list of pathogens of public health importance for which Antimicrobial drug development will be desirable. The committee will also discuss the concept of how preclinical data and clinical data from one disease state may support approval of antimicrobial drugs in another state.

 

       
Location: Marriott Rio Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Subcommittee/Anti-Infective Drugs AdComm

Meeting Date: 3/3/03-3/3/03

Meeting Details:

On March 3, 2003, the subcommittee will discuss the development of antiretroviral drugs in HIV-infected and HIV-exposed neonates younger than four weeks of age. Following this at 2:45 p.m., the agency will provide an update to the subcommittee on the Adverse Event Reporting plan as mandated in Section 17 of the Best Pharmaceuticals for Children Act. After this presentation, at approximately 3:45 p.m., the agency will provide an update on pediatric initiatives within the agency.

 

       
Location: FDA Fishers Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs Advisory Committee

Meeting Date: 1/8/03-1/9/03

Meeting Details:

On January 8, 2003, the committee will discuss new drug application (NDA) 21-144, KETEK (telithromycin), Aventis Pharmaceuticals, Inc., proposed for treatment of community-acquired pneumonia, acute exacerbation of chronic bronchitis, and acute maxillary sinusitis. On January 9, 2003, the committee will discuss issues pertaining to the contents in the document entitled ``Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine (Appendix A of the ``Draft Guidance for Industry: Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern'') (see the FDA Internet site at: http://www.fda.gov/cvm/guidance/dguide152.doc) as it relates to the process for evaluating antimicrobial resistance concerns for the Center for Veterinary Medicine's preapproval safety evaluation of a new animal drug.

 

       
Location: Marriott Washingtonian Center Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs Advisory Committee

Meeting Date: 7/10/02-7/11/02

Meeting Details:

On July 10, 2002 the committee will discuss NDA 21-242 for artesunate rectocaps for malaria. The meeting will be sponsored by the World Health Organization. On July 11, 2002 the committee will discuss clinical trial design for otitis media.

 

       
Location: Marriott Gaithersburg, Md. Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Subcommittee of the Anti-Infective AC

Meeting Date: 6/11/02-6/11/02

Meeting Details:

Beginning at 8 a.m., the subcommittee will discuss and receive comments on the ``written request template'' for the proton pump inhibitors in the treatment of gastroesophageal reflux disease in pediatric patients. Starting at 1 p.m., the subcommittee will discuss a ``preliminary priority list'' of drugs for which: (1) Additional studies are needed to assess the safety and effectiveness of the use of the drug in the pediatric population and (2) the drug has no remaining marketing exclusivity or patent protection. This list is mandated by the Best Pharmaceuticals for Children Act and the National Institutes of Health is the designated lead. At 4:30 p.m., representatives from Europe will provide information to the subcommittee on the ongoing pediatric initiatives in the European Union. Following this at 5 p.m., the agency will provide an update to the subcommittee on the pediatric labeling that has resulted from the exclusivity initiative under the FDA Modernization Act and the annual update on the pediatric rule, completed studies, deferrals, and waivers.

 

       
Location: Holiday Inn Bethesda, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Committee

Meeting Date: 2/19/02-2/20/02

Meeting Details:

On February 19, 2002, the committee will hear presentations on the proposed approach for selection of delta in noninferiority (equivalence) clinical trials. The impact of this approach on studies of anti-infective drug products will be considered, with a focus on acute exacerbation of chronic bronchitis and hospital-acquired- pneumonia. On February 20, 2002, the committee will discuss approaches to the development of antimicrobial agents for the treatment of resistant pathogens.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs Advisory Committee

Meeting Date: 11/7/01-11/7/01

Meeting Details:

The committee will consider the safety and efficacy of a new drug application (NDA) 50-710, Pfizer, Inc., for 1-day and 3-day dosing regimens of azithromycin suspension for the treatment of otitis media.

 

       
Location: Silver Spring Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs Advisory Committee

Meeting Date: 10/16/01-10/16/01

Meeting Details:

The committee will consider the safety and efficacy of Activated Protein C (human, recombinant, human kidney cells, new biologic license application (BLA) 125029), Eli Lilly & Co. for the treatment of severe sepsis. On 9/13/2001, the Anti-Infective Drugs Advisory Committee will review Bronchitis Trial Design: The committed will focus on trials in acute exacerbation of chronic bronchitis and hospital-acquired pneumonia.

 

       
Location: Silver Spring, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs Advisory Committee

Meeting Date: 4/26/01-4/26/01

Meeting Details:

The committee will consider the safety and efficiency of the new drug application (NDA) 21-144, Ketek™ (telithromycin) tablets, Aventis Pharmaceuticals, Inc., for the treatment of community-acquired pneumonia, acute exacerbation of chronic bronchitis, acute sinusitis, and tonsillitis/pharyngitis.

 

       
Location: Bethesda, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Subcommittee of the Anti-Infective Drugs Advisory Committee

Meeting Date: 4/23/01-4/24/01

Meeting Details:

On April 23, 2001, beginning at 8 a.m., the subcommittee will discuss issues in drug development for pediatric patients with chronic hepatitis C. Beginning at 3:30 p.m., the agency will provide an update to the subcommittee as to recent efforts to ensure adequate labeling and proper pediatric use of therapies. On April 24, 2001, the subcommittee will discuss issues involved in designing clinical trials to study anti-muscarinics for drooling in children with cerebral palsy and other neurologic diseases, as well as the ethical issues involved in performing studies with children having special needs.

 

       
Location: Rockville, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs Advisory Committee - Day 1 Cancelled

Meeting Date: 1/29/01-1/30/01

Meeting Details:

On January 29, 2001, the committee will consider the safety and efficacy of new drug application (NDA) 21-144, Ketek™ (telithromycin) tablets, Aventis Pharmaceuticals, Inc., for the treatment of community-acquired pneumonia, acute exacerbation of chronic bronchitis, acute sinusitis, and tonsillitis/pharyngitis. On January 30, 2001, the committee will consider the safety and efficacy of new drug application NDA 50-755, Augmentin ES™ (amoxicillin/clavulanate) 90 mg/kg/day, SmithKline Beecham Pharmaceuticals, for the treatment of pediatric patients with acute otitis media due to penicillin resistant Streptococcus pneumoniae.

 

       
Location: Gaithersburg, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Subcommittee of the Anti-Infective Drugs Advisory Committee

Meeting Date: 9/11/00-9/11/00

Meeting Details:

On September 11, 2000, beginning at 8 a.m., the subcommittee will discuss ethical considerations in the conduct of placebo-controlled clinical trials in the pediatric population. Beginning at 3 p.m., the subcommittee will discuss the development of psychotropic drugs for use in young children.

 

       
Location: Bethesda, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs

Meeting Date: 3/24/00-3/24/00

Meeting Details:

The committee will discuss new drug applications (NDA) 21-130, ZyvoxL (linezolid) tablets, NDA 21-131 ZyvoxL for injection (linezolid injection), and NDA 21-132 ZyvoxL Oral Suspension (linezolid oral suspension), Pharmacia & Upjohn Co., for treatment of community-acquired pneumonia, hospital-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and Vancomycin-resistant Enterococcus faecalis and faecium infections, including cases with concurrent bacteremia.

 

       
Location: Gaithersburg, MD. Related News Links: Not Available
Time: 8:30AM-5:30AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs

Meeting Date: 10/20/99-10/21/99

Meeting Details:

On the morning of October 20, the committee will discuss the development of antimicrobial drugs for the treatment of catheter-related bloodstream infections. On the afternoon of October 20, the committee will discuss new drug applications (NDA’s) 20-634 and 20-635, levofloxacin (Levaquin™, The R.W. Johnson Pharmaceutical Research Institute) for the treatment of community acquired pneumonia due to penicillin resistant S.pneumoniae. On October 21, the committee will discuss NDA 21-085, moxifloxacin (Avelox™, Bayer Corporation Pharmaceutical Division), for the treatment of community acquired pneumonia, acute bacterial exacerbations of chronic bronchitis, skin and skin structure infections, and acute sinusitis.

 

       
Location: Holiday Inn Silver Spring, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs

Meeting Date: 4/23/99-4/23/99

Meeting Details:

The subcommittee will discuss issues in the development and study of all therapies in children relative to the implementation of the agency’s new legislative and regulatory efforts to ensure adequate labeling and proper pediatric use.

 

       
Location: Holiday Inn Silver Spring Kennedy Grand Ballroom Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs

Meeting Date: 3/4/99-3/4/99

Meeting Details:

The committee will discuss new drug application 20-930, pexiganan acetate 1 percent topical cream (Magainin Pharmaceuticals) for treatment of infections in diabetic foot ulcers.

 

       
Location: Holiday Inn Kennedy Grand Ballroom 8777 Georgia Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs

Meeting Date: 10/15/98-10/16/98

Meeting Details:

The committee will discuss the development of drug products for resistant bacteria, including selective spectrum agents

 

       
Location: Holiday Inn Silver Spring, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs

Meeting Date: 7/29/98-7/31/98

Meeting Details:

On July 29, 30, and 31, 1998, the Committee will discuss guidance documents for guidance to industry on anti-microbial drug products for the treatment of infections being developed by the Office of Drug Evaluation IV’s Division of AntiInfective Drug Products and Division of Special Pathogens and Immunologic Drug Products.

 

       
Location: Hilton Hotel, Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs

Meeting Date: 2/19/98-2/19/98

Meeting Details:

NDAs 50-747 & 50-748 quinupristin/dalfopristin (Synercid(R), Rhone-Poulenc Rorer Pharmaceuticals) for treatment of vancomycin-resistant Enterococcus faecium (VREF) infections, complicated skin and skin structure infections, community-aquired and hospital aquired pneumonias, and for use in the treatment of infections cause by Staphylococcus aureus (including methicillin-susceptible and methicillin-restraint strains).

 

       
Location: Hilton Hotel Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs Advisory Committee

Meeting Date: 11/19/97-11/21/97

Meeting Details:

On November 19, 1997, the committee will discuss issues relating to the development of fluoroquinolones for use in pediatric patients. On the morning of November 20, 1997, the committee will discuss new drug application (NDA) 50-585/S046, ceftriaxone sodium (Rocephin sterile vials, Roche Laboratories) for single dose intramuscular treatment of acute otitis media. On the afternoon of November 20, 1997, the committee will discuss NDA 20-799, ofloxacin otic (Floxin, Daiichi Pharmaceuticals) for treatment of otitis externa, chronic suppurative otitis media with perforated tympanic membrane, and acute otitis media in pediatric patients with tympanostomy tubes. On November 21, 1997, the committee will discuss NDA 50-753, tobramycin solution for inhalation (TOBI, PathoGenesis Corp.) for the management of cystic fibrosis patients.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs Advisory Committee

Meeting Date: 3/5/97-3/7/97

Meeting Details:

On the morning of March 5, 1997, the committee will discuss supplemental new drug application (NDA) 50-679/ S002 Maxipime for Injection (cefepime hydrochloride, Bristol- Myers Squibb), in the treatment of febrile episodes in neutropenic patients. In the afternoon of March 5, 1997, and on March 6 and 7, 1997, the committee will discuss the draft guidance document entitled ``Evaluating Clinical Studies of Antimicrobials in the Division of Anti-Infective Drug Products,'' which is currently in the Draft-Not for Implementation stage.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint OTC & Anti-Infective Drugs

Meeting Date: 1/22/97-1/22/97

Meeting Details:

Regulation of nonprescription healthcare antiseptic drug products

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Nonprescription/Reproductive/Anti-Infective/ Antiviral Drugs Advisory Committee

Meeting Date: 11/20/96-11/22/96

Meeting Details:

On November 20, 1996, the committees will jointly discuss issues relevant to the use of microbicidal topical vaginal agents against infection with sexually transmitted Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC). In light of the significant public health impact of these sexually transmitted diseases, and the difficulties related to the evaluation and promotion of topical vaginal agents as prophylaxis against CT and GC, FDA is soliciting opinions and advice from the advisory committees regarding the development of policy for topical vaginal bacteriocidal agents. Issues for discussion include: (1) The quality and type of data that are available to support the use of such agents as prophylaxis against CT and GC, (2) what additional data would be required by the agency to create a label for such agents, and (3) whom would the appropriate target audience be for such agents. The agency encourages investigators, academicians, and members of the pharmaceutical industry with information about the use of such agents as prophylaxis against infection with CT and GC to respond to this notice. On November 21, 1996, the committees will discuss guidelines for the development of vaginal products for preventing the transmission of the human immunodeficiency virus (HIV). On November 22, 1996, the committees will discuss proposals and guidances for clinical efficacy studies on marketed OTC vaginal spermicides. Issues for discussion will include the type of data and quality of both in vitro and in vivo data needed to support and ensure spermicidal efficacy in final formulation.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs Advisory Committee

Meeting Date: 7/24/96-7/25/96

Meeting Details:

On July 24, 1996, the committee will discuss issues relevant to: (1) The use of silver sulfadiazine cream 1% in the treatment of patients with chronic wounds; and (2) new drug application (NDA) 19-832, Sulfamylon Solution 5% (mafenide acetate, Mylan Pharmaceuticals, Inc.) for the control of bacterial colonization under moist dressings over meshed autografts on excised burn wounds. On July 25 and 26, 1996, the committee will discuss antibiotic resistance issues. In light of the significant public health impact of increasing bacterial resistance on the future usefulness of antimicrobial agents, FDA is soliciting from the advisory committee opinions and advice regarding the development of policy for antimicrobial drugs intended for the treatment of multidrug resistant (MDR) organisms. Issues for discussion include labeling for the treatment of MDR organism(s), and labeling as second line therapy versus empiric therapy since widespread empiric use may decrease the drug's potential usefulness for treating MDR organisms. The agency encourages investigators, academicians, and members of the pharmaceutical industry with information relevant to the treatment of infections caused by MDR organisms, including current approaches to antimicrobial drug development, to respond to this notice.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting Anti-Infective and Gastrointestinal Drugs Advisory Committee

Meeting Date: 12/13/95-12/13/95

Meeting Details:

The committees will meet jointly to discuss data relevant to: (1) Supplemental new drug application (NDA) 50-662/S10 for Biaxin Filmtab (clarithromycin tablets, Abbott Laboratories), clarithromycin in combination with omeprazole for the treatment of active duodenal ulcers and prevention of recurrence of duodenal ulcers associated with Helicobacter pylori; and (2) NDA 20-558 for ranitidine bismuth citrate tablets plus amoxicillin (Tritec, Glaxo Wellcome, Inc.), and NDA 20-559 for ranitidine bismuth citrate tablets plus clarithromycin (Tritec, Glaxo Wellcome, Inc.), for healing and prevention of duodenal ulcer relapse due to H. pylori infection when used in conjunction with clarithromycin or amoxicillin.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs

Meeting Date: 10/27/95-10/27/95

Meeting Details:

The committee will discuss the diagnosis of Helicobacter pylori related gastrointestinal disease and resistance implications of widespread Helicobacter pylori treatment.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Anti-Infective and the Gastrointestinal Drugs Advisory Committee

Meeting Date: 10/26/95-10/26/95

Meeting Details:

The committees will meet jointly to discuss treatment of Helicobacter pylori to reduce peptic ulcer recurrence and to discuss resistance implications of widespread Helicobacter pylori treatment.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs

Meeting Date: 11/17/94-11/17/94

Meeting Details:

The committee will discuss the validity of endoscopically-obtained maxillary sinus specimens versus antral puncture for the microbiological diagnosis of sinusitis. FDA public advisory committee meetings may have as many as four separable portions: (1) An open public hearing, (2) an open committee discussion, (3) a closed presentation of data, and (4) a closed committee deliberation.

 

       
Location: November 17, 1994, 8:30 a.m., Bethesda Holiday Inn, Versailles Ballroom, 8120 Wisconsin Ave., Bethesda, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs

Meeting Date: 9/23/94-9/23/94

Meeting Details:

The committee will discuss surrogate markers, such as pharmacokinetic parameters and microbiological inhibitory and cidal data, and whether these parameters can be used instead of clinical efficacy data to support an alternative dosing regimen for oral metronidazole in the treatment of Trichomonas vaginalis vaginitis.

 

       
Location: September 23, 1994, 8 a.m., Holiday Inn, Plaza Ballroom, 8777 Georgia Ave., Silver Spring, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsArthritis AdComm

Meeting Date: 2/9/16-2/9/16

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Meeting Details:

The committee will discuss biologics license application (BLA) 125544, for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab), submitted by Celltrion, Inc. The proposed indications (uses) for this product are: (1) Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy; (2) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn's disease; (3) reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy; (4) reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy; (5) reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy;1 (6) in combination with methotrexate, reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis; (7) reducing signs and symptoms in patients with active ankylosing spondylitis; (8) reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis; and (9) treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 7:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 2/18/16-2/18/16

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Meeting Details:

The Committee will discuss and make recommendations on clinical trial, postapproval study design, and physician training requirements for leadless cardiac pacemaker device technology. Specifically, the Committee will be asked to make recommendations on the acceptability of adverse event rates in acute and chronic timeframes as well as indications for use for this device type, given availability of other technologies with different adverse event profiles; required training and acceptability of observed learning curves for the new device type and necessary elements for postapproval study collection.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 2/19/16-2/19/16

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Meeting Details:

The Committee will discuss the premarket application for the DIAM Spinal Stabilization System. The DIAM Spinal Stabilization System is indicated for skeletally mature patients that have low back pain (with or without radicular pain) with current episode lasting less than 1 year in duration secondary to moderate lumbar degenerative disc disease (DDD) at a single level from L2-L5. DDD is confirmed radiographically with one or more of the following factors: (1) Patients must have greater than 2 millimeters of decreased disc height compared to the adjacent level; (2) scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; or (3) herniated nucleus pulposus. The DIAM device is implanted via a minimally invasive posterior approach. Amended: The Committee will discuss, make recommendations, and vote on information regarding the premarket application (PMA) for the DIAM Spinal Stabilization System, sponsored by Medtronic Sofamor Danek USA. The DIAM Spinal Stabilization System is indicated for skeletally mature patients that have moderate low back pain (with or without radicular pain) with current episode lasting less than 1 year in duration secondary to lumbar degenerative disc disease (DDD) at a single symptomatic level from L2-L5. DDD is confirmed radiologically with one or more of the following factors: (1) Patients must have greater than 2 mm of decreased disc height compared to the adjacent level; (2) scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; or (3) herniated nucleus pulposus. The DIAM device is implanted via a minimally invasive posterior approach.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 2/25/16-2/26/16

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Meeting Details:

On February 25, 2016, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for ``TOPAS Treatment for Fecal Incontinence,' by ASTORA Women's Health, LLC. The ``TOPAS Treatment for Fecal Incontinence' device is a sling device (mesh) to be implanted around the puborectalis muscle (a muscle that contributes towards the maintenance of fecal continence). The proposed Indication for Use (IFU) for the ``TOPAS Treatment for Fecal Incontinence' device, as stated in the PMA, is as follows: The ``TOPAS Treatment for Fecal Incontinence' is intended to treat women with fecal incontinence (also referred to as accidental bowel leakage) who have failed more conservative therapies. On February 26, 2016, during session I, the committee will discuss and make recommendations regarding the reclassification of urogynecologic surgical mesh instrumentation from class I to class II. The applicable product codes are those related to urogynecologic surgical mesh as follows: OTN and the associated device classification name, ``mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, multi-incision;' PAG and the associated device classification name, ``mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, female, multi-incision;' PAH and the associated device classification name, ``mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, single-incision mini-sling;' OTO and the associated device classification name, ``mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed;' PAJ and the associated device classification name, ``mesh, surgical, non-synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed;' OTP and the associated device classification name, ``mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed' and PAI and the associated device classification name, ``mesh, surgical, non-synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed.' Some examples of the means by which these devices perform these functions and their respective IFU/Intended Use (IU) statements are: Urogynecologic surgical mesh instrumentation is used: [cir] IFU/IU: To aid in insertion, placement, fixation, or anchoring of surgical mesh for procedures including transvaginal pelvic organ prolapse repair, sacrocolpopexy (transabdominal pelvic organ prolapse repair), treatment of female stress urinary incontinence. Examples of such surgical instrumentation include needle passers and trocars, needle guides, fixation tools, and tissue anchors. The committee, during session II, will discuss and make recommendations regarding the classification of the product code ``LKX' and the associated device classification name, ``Device, Thermal, Hemorrhoids.' The product code LKX represents a category of devices intended to apply controlled cooling and conductive heating to hemorrhoids. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are: Uses an aluminum probe that contains a temperature sensitive element to regulate temperature within 2 degrees (between 37 and 46 degrees centigrade). [cir] IFU/IU: The apparatus is intended to apply controlled, conductive heating to hemorrhoids. Uses a heat applicator inserted into the rectum, applicator contains a battery operated heater, and a sensor which provides temperature control/feedback. [cir] IFU/IU: Intended to provide temporary relief of the symptoms of hemorrhoids through the application of mild heating. Uses speculum-like plastic container containing liquid to cool hemorrhoidal veins. [cir] IFU/IU: Treatment of external hemorrhoids by applying cold therapy (cryotherapy) directly to swollen hemorrhoidal veins. The committee, during session III, will discuss and make recommendations regarding the classification of the product code ``LRL' and the associated device classification name, ``Cushion, Hemorrhoid.' The product code LRL represents a category of devices intended to temporarily relieve pain and pressure caused by hemorrhoids. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are: Uses an injection molded polypropylene copolymer plastic seat attached to a toilet seat (the product is adjustable and is available in round and elongated versions). [cir] IFU/IU: For the temporary relief from the pain and pressure of hemorrhoids. The device is for external use only. Uses a cushion with an inflatable vinyl exterior and a foam center. An air chamber, when filled, prevents the cushion from compressing the foam. A urethane foam center adds comfort. [cir] IFU/IU: Intended for the home convalescent patient with perineal discomfort. Uses a cushion that contains two internal molded structures that conform to the patient's shape. Exerts ``slight' pressure on hemorrhoid. IFU/IU not required at the time of clearance. The committee, during session IV, will discuss and make recommendations regarding the classification of the product code ``LKN' and the associated device classification name, ``Separator, automated, blood cell and plasma, therapeutic.' The product code LKN represents a category of centrifuge-type devices intended to separate blood components and perform therapeutic plasma exchange for the management of serious medical conditions in adults and children. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments [[Page 940]] became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are: Utilizes a continuous flow centrifuge (max speed 3000 revolutions per minute) to separate source blood from a subject into blood components. [cir] IFU/IU: May be used to perform therapeutic plasma exchange. [cir] IFU/IU: May be used to perform Red Blood Cell Exchange procedures for the transfusion management of Sickle Cell Disease in adults and children. Uses continuous flow access to a rotating centrifuge to separate blood components. [cir] IFU/IU: May be used to harvest cellular components from the blood of certain patients where the attending physician feels the removal of such component may benefit the patient. [cir] IFU/IU: May be used to remove plasma components and/or fluid selected by the attending physicians.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 3/4/16-3/4/16

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Meeting Details:

On March 4, 2016, the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2016-2017 influenza season.

 

       
Location: TBD Related News Links: Not Available
Time: 8:30AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 3/15/16-3/16/16

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Meeting Details:

On March 15, 2016, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System sponsored by Abbott Vascular. The Absorb GT1 BVS System is a temporary scaffold that will fully resorb over time and is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions (length = 24 millimeters (mm)) with a reference vessel diameter of = 2.5 mm and = 3.75 mm. On March 16, 2016, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the AngelMed Guardian System sponsored by Angel Medical Systems, Inc. The AngelMed Guardian System is an implantable cardiac monitor intended to alert patients to ST segment shifts indicating coronary ischemia. The AngelMed Guardian System is intended for use in patients with prior acute coronary syndrome events, and at risk for recurrent events, to ST segment changes indicating cardiac ischemia.

 

       
Location: Holiday Inn Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs Advisory Committee

Meeting Date: 2/3/16-2/3/16

Meeting Details:

During the morning session, the committee will discuss cognitive dysfunction in major depressive disorder (MDD). This is an evolving concept and experts in the field have not yet reached consensus as to whether cognitive dysfunction in MDD is a distinct entity. The committee will consider the clinical presentation of cognitive dysfunction in MDD, as well as methods for assessing this condition. During the afternoon session, the committee will discuss new drug application 204447/supplemental new drug application 006, for the effectiveness of vortioxetine for the treatment of cognitive dysfunction in MDD, submitted by Takeda Development Center Americas, Inc.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPOSTPONED: Peripheral and Central Nervous System Drugs AdComm

Meeting Date: 1/22/16-1/22/16

Meeting Details:

The postponement is due to inclement weather forecasted for the Washington, DC area. The committee will discuss new drug application 206488, eteplirsen injection for intravenous infusion, sponsored by Sarepta Therapeutics, Inc., for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAllergenic Products AdComm

Meeting Date: 1/21/16-1/21/16

Meeting Details:

The committees will discuss safety and effectiveness data, including challenge study endpoints, for licensure of food allergy immunotherapy products, and the clinical development of aeroallergen immunotherapy products for the prevention of respiratory allergic disease.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs AdComm - PROBUPHINE

Meeting Date: 1/12/16-1/12/16

Meeting Details:

The committee will discuss new drug application (NDA) 204442, PROBUPHINE (buprenorphine hydrochloride and ethylene vinyl acetate) subdermal implant, submitted by Braeburn Pharmaceuticals, Inc., on behalf of Titan Pharmaceuticals for the proposed indication of maintenance treatment of opioid dependence.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Past Meetings

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