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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm - Sponsor: Shionogi Inc.

Meeting Date: 10/16/19-10/16/19

Meeting Details:

The committee will discuss new drug application (NDA) 209445, cefiderocol lyophilized powder for intravenous administration, submitted by Shionogi Inc., for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis due to gram-negative bacteria in patients with limited or no alternative treatment options.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs Advisory Committee

Meeting Date: 8/7/19-8/7/19

Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 208215, supplement 12, DESCOVY (emtricitabine 200 milligrams (mg) and tenofovir alafenamide 25 mg tablets), submitted by Gilead Sciences, Inc., proposed for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative and at risk for HIV.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-2:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 6/6/19-6/6/19

Meeting Details:

The committee will discuss new drug application (NDA) 212862, pretomanid tablets for oral administration, submitted by The Global Alliance for TB Drug Development, Inc., proposed as part of a combination regimen with bedaquiline and linezolid in adults for the treatment of pulmonary extensively drug resistant and treatment-intolerant or non-responsive multidrug-resistant tuberculosis (TB).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 8/7/18-8/7/18

Meeting Details:

The committee will discuss new drug application (NDA) 207356, amikacin liposome inhalation suspension, sponsored by Insmed, Inc., for the proposed indication of treatment of nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex in adults as part of a combination antibacterial drug regimen.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 7/26/18-7/26/18

Meeting Details:

The committee will discuss new drug application (NDA) 210607, tafenoquine tablet, 100 milligram (mg), sponsored by 60 Degrees Pharmaceuticals, LLC, for the proposed indication of prevention of malaria in adults for up to 6 months of continuous dosing.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 7/12/18-7/12/18

Meeting Details:

The committee will discuss new drug application (NDA) 210795, tafenoquine tablet, 150 milligram, sponsored by GlaxoSmithKline Intellectual Property Development Ltd., England, for the proposed indication of the radical cure (prevention of relapse) of Plasmodium vivax malaria.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 5/2/18-5/2/18

Meeting Details:

The committee will discuss new drug application (NDA) 210303 for plazomicin, sponsored by Achaogen, Inc., for the proposed indications for the treatment of complicated urinary tract infections and blood stream infections in adults.

 

       
Location: DoubleTree by Hilton Hotel Bethesda Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 5/1/18-5/1/18

Meeting Details:

The committee will discuss new drug application (NDA) 208627 for tecovirimat, sponsored by SIGA Technologies Inc., for the proposed indication of the treatment of smallpox disease caused by variola virus in adults and pediatric patients. This product was developed under the Animal Rule (21 CFR part 314, subpart I).

 

       
Location: DoubleTree by Hilton Hotel Bethesda Related News Links: Not Available
Time: 10:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 1/11/18-1/11/18

Meeting Details:

The committee will discuss new drug application (NDA) 210693, ciprofloxacin dispersion for inhalation, sponsored by Aradigm Corp., for the proposed indication of treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa.

 

       
Location: College Park Marriott Hotel and Conference Center Chesapeake Ballroom 3501 University Blvd. East Hyattsville, MD 20783 Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs Advisory Committee

Meeting Date: 11/16/17-11/16/17

Meeting Details:

The committee will discuss new drug application (NDA) 209367, ciprofloxacin inhalation powder, sponsored by Bayer HealthCare Pharmaceuticals, Inc., for the proposed indication of reduction of exacerbations in non-cystic fibrosis bronchiectasis (NCFB) adult patients (=18 years of age) with respiratory bacterial pathogens.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs Advisory Committee

Meeting Date: 4/13/17-4/13/17

Meeting Details:

The committee will discuss the development of antibacterial drugs that treat a single species of bacteria when the target species infrequently causes infections; examples of such drugs include those that are only active against Pseudomonas aeruginosa or Acinetobacter baumannii.

 

       
Location: Tommy Douglas Conference Center Silver Spring, MD Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting of the Antimicrobial Drugs Advisory Committee

Meeting Date: 11/4/16-11/4/16

Meeting Details:

The committee will discuss new drug applications 209006 and 209007, solithromycin capsules and solithromycin for injection, sponsored by Cempra Pharmaceuticals, Inc., respectively for the proposed indication of treatment of community-acquired bacterial pneumonia (CABP).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs Advisory Committee

Meeting Date: 6/9/16-6/9/16

Meeting Details:

The committee will discuss biologics license application (BLA) 761046, bezlotoxumab (MK-6072) injection, submitted by Merck Sharpe & Dohme Corp., for the proposed indication of prevention of Clostridium difficile infection recurrence.

 

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

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Upcoming Meetings

Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsAllergenic Products Advisory Committee

Meeting Date: 5/15/20-5/15/20

Meeting Details:

The Center for Biologics Evaluation and Research's (CBER) Allergenic Products Advisory Committee (APAC) will meet in open session to discuss and make recommendations on the safety and efficacy of Peanut (Arachis hypogaea) Allergen Extract manufactured by DBV Technologies, S.A for treatment of patients 4 through 11 years old with a confirmed diagnosis of peanut allergy.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue and Gene Therapies Advisory Committee

Meeting Date: 5/8/20-5/8/20

Meeting Details:

On May 8, 2020, the committee will meet by teleconference. In open session, the committee will hear an overview and updates of research programs in the Tumor Vaccines and Biotechnology Branch (TVBB) and Cellular and Tissue Therapy Branch (CTTB), Division of Cellular and Gene Therapies (DCGT), Office of Tissues and Advanced Therapies (OTAT), CBER, FDA.

 

       
Location: VIRTUAL Related News Links: Not Available
Time: 1:00AM-4:55AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 4/29/20-4/29/20

Meeting Details:

tbd

 

       
Location: tbd Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Past Meetings

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