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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs AdComm

Meeting Date: 10/25/13-10/25/13

Meeting Details:

The committee will discuss new drug application (NDA) 204671, sofosbuvir (an NS5B polymerase inhibitor), manufactured by Gilead Sciences, Inc., with a proposed indication for the treatment of chronic hepatitis C infection, in combination with other agents in adult patients with genotypes 1 to 6 and/or adult patients awaiting liver transplantation.

 

       
Location: Sheraton Silver Spring Hotel Cypress Ballroom 8777 Georgia Avenue Silver Spring, Maryland Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs AdComm

Meeting Date: 10/24/13-10/24/13

Meeting Details:

The committee will discuss new drug application (NDA) 205123, simeprevir (a hepatitis C virus protease inhibitor), manufactured by Janssen Pharmaceutical Co., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin (two medicines approved to treat chronic hepatitis C) in adult patients with compensated liver disease (including cirrhosis) who are treatment-naïve or who have failed previous interferon therapy (pegylated or non-pegylated) with or without ribavirin. Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs Advisory Committee

Meeting Date: 5/11/12-5/11/12

Meeting Details:

The committee will discuss new drug application (NDA) 203-100, for a fixeddose combination tablet of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate, submitted by Gilead Sciences, Inc. The application proposes an indication for the treatment of HIV-1 infection in adults who are antiretroviral naïve or have no known substitutions associated with resistance to the individual components.

 

       
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 OptionsAntiviral Drugs Advisory Committee

Meeting Date: 5/10/12-5/10/12

Meeting Details:

The committee will discuss an efficacy supplement for new drug application (NDA) 21-572, TRUVADA (emtricitabine/tenofovir disoproxil fumarate) Tablet, submitted by Gilead Sciences, Inc. The supplemental application proposes an indication for Pre-Exposure Prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs Advisory Committee

Meeting Date: 12/14/11-12/15/11

Meeting Details:

On December 14 and 15, 2011, the committee will discuss pathways for the development of drugs intended to treat variola virus infection (smallpox) in the event of an outbreak, including the use of animal models of other orthopoxviruses (the group of viruses that includes smallpox) as potential evidence of efficacy.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs AdComm

Meeting Date: 4/27/11-4/28/11

Meeting Details:

On April 27, 2011, the committee will discuss a new drug application (NDA) 202-258, boceprevir (a hepatitis C virus protease inhibitor), manufactured by Merck & Co., Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin (two medicines approved to treat chronic hepatitis C infection) in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Compensated liver disease is a stage in which the liver is damaged but maintains ability to function. On April 28, 2011, the committee will discuss a new drug application (NDA) 201-917, telaprevir (a hepatitis C virus protease inhibitor), manufactured by Vertex Pharmaceuticals, Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin (two medicines approved to treat chronic hepatitis C infection) in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs AdComm

Meeting Date: 6/2/10-6/2/10

Meeting Details:

On June 2, 2010, the committee will discuss biologics license application (BLA) 125283, motavizumab, MedImmune, LLC, proposing an indication for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs AdComm

Meeting Date: 10/8/09-10/8/09

Meeting Details:

The committee will discuss an efficacy supplement for new drug application (NDA) 022-128, maraviroc 300 milligram tablets, Pfizer, Inc., proposing a new indication for the treatment of antiretroviral-naive patients with chemokine (c-c motif) receptor 5 (CCR5--tropic human immunodeficiency virus (HIV).

 

       
Location: University of Maryland Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs AdComm

Meeting Date: 12/2/08-12/2/08

Meeting Details:

On December 2, 2008, the committee will begin with a closed session from 8 a.m. to 10:30 a.m., to permit discussion and review of trade secret and/or confidential information. Following the closed session, from 10:30 a.m. to 5 p.m., the meeting will be open to the public. The committee will discuss the safety and efficacy of new drug application (NDA) 20-725, Creon (pancrelipase delayed-release capsules), Solvay Pharmaceuticals, Inc., for the treatment of exocrine pancreatic insufficiency.

 

       
Location: Hilton Washington DC/Silver Spring Silver Spring, MD. Related News Links: Not Available
Time: 10:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Antiviral and Nonprescription AdComm

Meeting Date: 10/29/08-10/29/08

Meeting Details:

The committee will provide advice on types of studies and trial designs needed for an influenza antiviral MedKit for the treatment or prophylaxis of pandemic influenza and discuss publicly the proposed development program that would support an application for such a MedKit. Issues such as the role of personal MedKits, home stockpiling, non-prescription availability of influenza medications, and interfaces of home readiness with public health systems, will be raised in the course of the discussions.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs AdComm

Meeting Date: 9/5/07-9/5/07

Meeting Details:

On September 5, 2007, the committee will discuss new drug application (NDA) 22–145, raltegravir potassium, integrase inhibitor 400 milligram tablets, Merck & Co., Inc., for the treatment of Human Immunodeficiency Virus-1 (HIV–1) infection in combination with other antiretroviral agents in treatment-experienced patients with evidence of HIV–1 replication despite ongoing antiretroviral therapy.

 

       
Location: Hilton - Silver Spring, MD Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs AdComm

Meeting Date: 4/24/07-4/24/07

Meeting Details:

The committee will discuss new drug application (NDA) 022- 128, maraviroc 300 milligram tablets, Pfizer, Inc., proposed for the treatment of antiretroviral-experienced patients with chemokine (c-c motif) receptor 5 (CCR5)--tropic human immunodeficiency virus (HIV).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs AdComm

Meeting Date: 10/19/06-10/20/06

Meeting Details:

On both days, the committee will discuss clinical trial design issues in the development of products for treatment of chronic hepatitis C infection. This meeting is being convened in response to the growing number of products in development for this indication. The primary objectives for committee deliberations are to discuss issues relating to the identification of appropriate control arms, populations for study, endpoints, and long-term followup. On October 20, 2006, the meeting will be open to the public from 8 a.m. to 12 noon, unless public participation does not last that long; from 1 p.m. to 4 p.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential information.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs

Meeting Date: 5/19/05-5/19/05

Meeting Details:

The committee will discuss new drug application (NDA) 21-814, proposed trade name APTIVUS (Tipranavir) 250 milligram capsules, Boehringer Ingelheim Pharmaceuticals, Inc., indicated for the treatment of patients with human immunodeficiency virus HIV.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs AdComm

Meeting Date: 3/11/05-3/11/05

Meeting Details:

On march 11, 2005, The FDA committee will discuss NDA 21-797 and NDA 21-798 entecavir tablets and oral solution by Bristol-Myers Squibb’s proposed treatment for patients with chronic hepatitis B infection (HBV). Source: FDA AdComm Hotline

 

       
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: 10/14/04-10/14/04

Meeting Details:

The committee will discuss the following topics: (1) Issues related to clinical trial design and analysis in studying catheter-related bacteremia and (2) issues related to clinical trial design and analysis in studying bacteremia due to staphylococcus aureus.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs AdComm

Meeting Date: 8/20/03-8/20/03

Meeting Details:

On August 20, the committee will discuss clinical trial design issues in the development of topical microbicide for the reduction of HIV transmission.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs Advisory Committee

Meeting Date: 5/13/03-5/14/03

Meeting Details:

On May 13, 2003, the committee will discuss new drug applications (nDA) 21-567 and 21-568, Reyataz (atazanavir sulfate) capsules and powder for oral use, Bristol-Myers Squibb Company, proposed for the treatment of HIV infection in combination with other antiretroviral agents. On May 14, 2003, the committee will discuss supplemental new drug application (sNDA) 20-550/S-019, Valtrex (valacyclovir hydrochloride) caplets, GlaxoSmithKline, proposed for reduction of the risk of transmission of genital herpes with the use of suppressive therapy.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs Ad Comm

Meeting Date: 11/14/02-11/14/02

Meeting Details:

On Nov 14, The committee will discuss Peg Interferon / co-packaged with Ribavirin sponsored by Hoffman La-Roche Inc. purposed as combination therapy for the treatment of chronic hepatitis C.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs AC

Meeting Date: 8/6/02-8/7/02

Meeting Details:

On August 6th, the committee will discuss NDA21449 Adefovir Dipivoxil tablets sponsored by Gilead Sciences Inc. proposed for treatment of chronic hepatitis B infection. On August 7th, the committee will discuss clinical trial design issues in development of products for treatment of hepatits B infection.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs Advisory Committee

Meeting Date: 3/19/02-3/19/02

Meeting Details:

The committee will discuss new drug application (NDA) 21- 245, Picovir (pleconaril), ViroPharma Inc., proposed for treatment of acute viral respiratory infection (the common cold) in adults.

 

       
Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., Gaithersburg, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs Advisory Committee

Meeting Date: 1/24/02-1/24/02

Meeting Details:

The subcommittee will discuss new drug applications (NDAs)21-083/SE1-006 and 21-110/SE1-004, RAPAMUNE (sirolimus) oral solution and tablets, Wyeth-Ayerst Research, approved for prophylaxis of organ rejection in patients receiving renal transplants. As stated in the approved labeling, it is recommended that RAPAMUNE be used in a regimen with cyclosporine and corticosteroids. The discussion is for the proposed elimination of cyclosporine from the immunosuppressive regimen 2 to 4 months after transplantation under certain conditions.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs Advisory Committee

Meeting Date: 12/12/01-12/12/01

Meeting Details:

The committee will be updated on the approval of biologics license application supplement (BLs) 103949/5002, PEG-Intron™, (peginterferon alpa-2b) Powder for Injection, Schering Corporation, indicated for use alone or in combination with Rebetol (ribavirin, USP), for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and are at least 18 years of age.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs Advisory Committee

Meeting Date: 10/3/01-10/4/01

Meeting Details:

On October 3, 2001, the committee will discuss new drug application (NDA) 21-356, VireadTM (tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., proposed for the treatment of human immunodeficiency virus (HIV) infection. On October 4, 2001, the committee will discuss NDA 21-266, VfendTM (voriconazole) Tablets and NDA 21-267, VfendTM I.V. (voriconazole) for infusion, Pfizer Global Research and Development, proposed for the treatment of invasive aspergillosis, serious Candida infections, infections caused by Scedosporium spp. and Fusarium spp., rare and refractory infections, and empirical treatment of febrile neutropenia.

 

       
Location: Town Center Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs Advisory Committee

Meeting Date: 2/27/01-2/27/01

Meeting Details:

The committee will discuss new drug application (NDA) 21-304, valganciclovir hydrochloride tablets, 450mg, Syntex (U.S.A.) LLC, proposed for treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome (AIDS).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs Advisory Committee

Meeting Date: 1/10/01-1/11/01

Meeting Details:

---- DAY 1 ----The committee will discuss new drug application (NDA) 21-227, Cancidas™ (caspofungin) Injection, Merck Research Laboratories, indicated for treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies. ---- DAY 2 ---- Presentations and committee discussions will focus on clinical trial design issues for patients with HIV-1 infection who have limited therapeutic options (treatment sometimes referred to as "salvage" therapy). This meeting is being convened in response to the recognized difficulty in evaluating the safety and effectiveness of new antiretroviral therapeutics in heavily pretreated patients. A further goal of this meeting is to facilitate and promote the development of new therapies for patients who are most in need of new therapeutic options. For the purpose of this meeting, we will define "salvage" therapy as regimens that follow a loss or lack of virologic response to at least two previous antiretroviral regimens that, in total, have consisted of drugs from all of the approved drug classes (protease inhibitors, nucleoside and non-nucleoside reverse transcriptase inhibitors). This population of heavily pretreated patients reflects a population for whom selection of active controls in clinical trials is a particular challenge.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs

Meeting Date: 10/16/00-10/16/00

Meeting Details:

The committee will discuss the use of surrogate markers in the early development of immunomodulatory agents for the treatment of patients with human immunodeficiency virus (HIV).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs

Meeting Date: 7/25/00-7/25/00

Meeting Details:

On July 25, 2000, the committee will discuss scientific data characterizing relationships of pharmacokinetic parameters and virologic response to approved antiretroviral drugs used in the treatment of human immunodeficiency virus (HIV) infection. The primary objectives for the committee deliberations are to explore the use of pharmacokinetic data to improve the evaluation of new formulations, alternative dosing regimens, and choice of dosing in the setting of drug-drug interactions for approved antiretroviral drugs. Additionally, other issues to be discussed include: the relationship between pharmacokinetic parameters and drug toxicity, and safety requirements and pediatric considerations for alternative dosing regimens.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs

Meeting Date: 11/1/99-11/3/99

Meeting Details:

On the 1st of November, the committee will discuss adefovir dipivoxil (Gilead Sciences Inc.), for the treatment of human immunodeficiency virus infection. On the 2nd & 3rd of November, They will discuss issues related to testing for development of resistant human immunodeficiency virus (HIV-1), with an emphasis on its potential role in antiretroviral drug development. The primary objectives of these deliberations are to obtain advisory committee recommendations on the amount and type of resistance data needed to support both preclinical and clinical development of antiretroviral drugs & product labeling.

 

       
Location: Holiday Inn The Ballrooms Two Montgomery Village Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs

Meeting Date: 10/4/99-10/5/99

Meeting Details:

On October 4, 1999, presentations and committee discussions will address issues related to the potential applicability of information from non-U.S. studies of prevention of perinatal human immunodeficiency virus transmission to U.S. clinical settings.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs

Meeting Date: 7/27/99-7/27/99

Meeting Details:

The subcommittee will discuss the new drug application (NDA) 21-083, Rapamune (sirolimus, Wyeth-Ayerst Laboratories) for the prophylaxis of organ rejection in patients receiving renal transplants. *** Call for Satellite, Videoconferencing and Webcasting ***

 

       
Location: Holiday Inn Goshen/Walker/Whetstone Rooms Two Mo Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs

Meeting Date: 2/24/99-2/24/99

Meeting Details:

The committee will discuss new drug application (NDA) 21- 036, zanamivir for inhalation (Relenza, Glaxo Wellcome, Inc.), for the treatment of influenza A and B.

 

       
Location: Holiday Inn Walker/Whetstone Rooms Two Montgomer Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs

Meeting Date: 11/2/98-11/2/98

Meeting Details:

The committee will discuss new drug applications (NDA) 20-977 (tablets) and 20-978 (oral solution) for abacavir sulfate (Ziagen, Glaxo Wellcome, Incorporated) for the treatment of human immunodeficiency virus (HIV) infection

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs

Meeting Date: 10/6/98-10/6/98

Meeting Details:

The committee will discuss new drug applications (NDA) N21-003 (100-milligram (mg) tablets) and NDA N21-004 (5 mg/milliliter oral solution) for lamivudine (Epivir HBV, Glaxo Wellcome, Inc.) for the treatment of chronic hepatitis B.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs

Meeting Date: 7/14/98-7/15/98

Meeting Details:

On the morning of July 14, 1998, the committee will hear presentations on general regulatory procedures and policies including: the use of HIV RNA as an endpoint for accelerated and traditional approvals, FDA’s initiatives to encourage pediatric drug development, implications of the FDA modernization act (FDAMA) for the regulation of antiviral drug products, and the current mechanisms for post-marketing surveillance. Antiretroviral class adverse events, including those observed with HIV protease inhibitors, will be presented to illustrate post-marketing surveillance procedures.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs

Meeting Date: 5/4/98-5/6/98

Meeting Details:

On May 4, 1998, the committee will discuss New Drug Application (NDA) 20-903, Intron®A/Rebetol (interferon alfa-2b, recombinant/ribavirin, Schering Corporation) for the treatment of chronic hepatitis C. On May 5, 1998, the committee will discuss NDA 50-752, Priftin® (rifapentine, Hoechst Marion Roussel, Inc.) for the treatment of pulmonary tuberculosis. On May 6, 1998, the committee will discuss NDA 20-871, NTZTM (nitazoxanide, UNIMED Pharmaceuticals, Inc.)for the treatment of diarrhea associated with cryptosporidiosis in AIDS patients.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs Advisory Committee

Meeting Date: 7/14/97-7/16/97

Meeting Details:

On July 14 and 15, 1997, the committee will discuss the utility of plasma human immunodeficiency virus (HIV) RNA measurement as an endpoint in clinical trials for drugs to treat HIV infection. In light of the rapid changes in knowledge about the pathophysiology of HIV infection, the advances in the technologies to quantify HIV in plasma, and the evolution of antiviral therapy, FDA is soliciting opinions and advice from the advisory committee on this topic. On July 16, 1997, the committee will discuss data relevant to new drug application (NDA) 50-740, AmBisome (liposomal amphotericin B, Fujisawa, USA), as empirical therapy for presumed fungal infection in febrile neutropenic patients.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs Advisory Committee

Meeting Date: 4/14/97-4/14/97

Meeting Details:

The committee will discuss data relevant to a supplemental new drug application for the approved drug, Amphotec TM, (amphotericin B cholesteryl sulfate complex, Sequus Pharmaceuticals, Inc.), for use in the empiric therapy of febrile neutropenic patients.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs Advisory Committee

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

Meeting Details:

The committee will discuss data relevant to new drug application (NDA) 20-705, Rescriptor, (delavirdine, Pharmacia and Upjohn Co.) for use in the treatment of HIV infection.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs Advisory Committee

Meeting Date: 6/6/96-6/7/96

Meeting Details:

On June 6, 1996, the committee will discuss data relevant to new drug application (NDA) 20-585, Bravavir (sorivudine), Bristol Myers Squibb, for use in the treatment of herpes zoster in immunocompromised adults. On June 7, 1996, the committee will discuss data relevant to NDA 20-636, Viramune (nevirapine), Boehringer Ingelheim, for use in the treatment of human immunodeficiency virus infection.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting Antiviral Dermatologic & Ophthalmic Drugs Advisory Committee

Meeting Date: 3/15/96-3/15/96

Meeting Details:

On March 15, 1996, the Antiviral Drugs Advisory Committee and an ophthalmic drugs subcommittee of the Dermatologic and Ophthalmic Drugs Advisory Committee will meet jointly to discuss data relevant to NDA 20-638 Vistide TM (cidofovir, intravenous, Gilead Sciences, Inc.) for treatment of cytomegalovirus (CMV) retinitis in patients with AIDS.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs

Meeting Date: 2/28/96-3/1/96

Meeting Details:

On February 28, 1996, the committee will discuss recent studies with nucleoside analogues for the treatment of human immunodeficiency virus (HIV) infection. The discussion will include data from AIDS Clinical Trial Group (ACTG) Study 175, the Delta studies, and other relevant studies. Data pertinent to the following NDA's will be included in the discussion: Bristol Myers Squibb NDA's 20-154, 20-155, and 20-156 for Videx (didanosine) chewable tablets, buffered powder for oral solution, and pediatric powder for oral solution; Glaxo Wellcome NDA's 19-665 and 19-910 for Retrovir (zidovudine) capsules and syrup; Roche Laboratories' NDA 20-199 for HIVID (zalcitabine) tablets. On February 29, 1996, the committee will discuss data relevant to NDA's 20-659 and 20- 680 ritonavir (liquid and capsules, Abbott Laboratories) for treatment of HIV infection. On March 1, 1996, the committee will discuss data relevant to NDA 20-685 Crixivan TM (indinavir capsules, Merck and Co., Inc.) for treatment of HIV infection.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs Advisory Committee

Meeting Date: 11/6/95-11/8/95

Meeting Details:

On November 6, 1995, the committee will discuss data relevant to new drug applications (NDA's) 20-564 (tablets) and 20-596 (oral solution) for lamivudine (Epivir TM, also known as 3TC), sponsored by Glaxo Wellcome. On November 7, 1995, the committee will discuss data relevant to NDA 20-628 for saquinavir (Invirase TM), sponsored by Hoffman-La Roche. On November 8, 1995, the committee will discuss confirmatory trials of stavudine (Zerit TM, also known as d4T), sponsored by Bristol-Myers Squibb. All products listed above are for the treatment of human immunodeficiency virus infection.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs Advisory Committee

Meeting Date: 9/8/95-9/8/95

Meeting Details:

The National Task Force on AIDS Drug Development shall identify any barriers and provide creative options for the rapid development and evaluation of treatments for human immunodeficiency virus (HIV) infection and its sequelae. It also advises on issues related to such barriers, and provides options for the elimination of these barriers. The Antiviral Drugs Advisory Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of acquired immune deficiency syndrome (AIDS), AIDS-related complex (ARC), and other viral, fungal, and mycobacterial infections.

 

       
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: 7/20/95-7/20/95

Meeting Details:

During the morning of July 20, 1995, the committee will discuss treatment goals of the short-term therapy of cystitis, including safety and efficacy data for the fosfomycin tromethamine NDA 50-717, Forest Laboratories, Inc./Zambon Corp. During the afternoon, the committee will revisit the FDA/Infectious Diseases Society of America guidelines for evaluating new treatment regimens for urinary tract infections.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs

Meeting Date: 4/3/95-4/3/95

Meeting Details:

The committee will hear presentations and discuss scientific issues relevant to liposomal antifungal agents.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint OTC & Antiviral Drugs

Meeting Date: 1/12/95-1/12/95

Meeting Details:

The committee will discuss Zovirax Rx to over-the-counter Switch.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs

Meeting Date: 11/17/94-11/18/94

Meeting Details:

On November 17, 1994, the committee will discuss data relevant to NDA 20-460 for oral ganciclovir (Cytovene, Syntex Laboratories, Inc.) for the treatment of cytomegalovirus retinitis in immunocompromised patients, where the retinitis is stable after prior therapy. On November 18, 1994, the committee will hear scientific presentations on aspects of clinical trial design for drugs used for hepatitis. Closed committee deliberations. On November 18, 1994, the committee will discuss trade secret and/or confidential commercial information relevant to pending NDA's.

 

       
Location: November 17, 1994, 8:30 a.m., and November 18, 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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Meeting OptionsMeeting OptionsMeeting OptionsJoint Anti-Infective & Dermatologic Drugs

Meeting Date: 11/16/94-11/16/94

Meeting Details:

The committee will jointly discuss the potential for development of antibiotic resistance with over-the- counter use of topical erythromycin in the treatment of acne.

 

       
Location: November 16, 1994, 8 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 OptionsAntiviral Drugs

Meeting Date: 9/12/94-9/13/94

Meeting Details:

The committee will discuss scientific and medical issues relevant to the validation of surrogate markers for use as criteria in regulatory decisionmaking.

 

       
Location: September 12 and 13, 1994, 8:30 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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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs

Meeting Date: 7/28/94-7/28/94

Meeting Details:

The committee will discuss data submitted in support of supplementary new drug applications (NDA's) 19- 655 (supplement 023), 19-910 (supplement 011), and 19-951 (supplement 003) for zidovudine (Retrovir, Burroughs Welcome) for use as prophylaxis against maternal to fetal transmission of HIV infection.

 

       
Location: July 29, 1994, 8 a.m., Parklawn Bldg., conference rms. G, H, I, and J, FDA 5600 Fishers Lane, Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 11/6/14-11/6/14

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Meeting Details:

During the morning session, the committee will discuss New Drug Application (NDA) 205353, panobinostat capsules, application submitted by Novartis Pharmaceuticals Corporation. The proposed indication (use) for this product is in combination with bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least 1 prior therapy. During the afternoon session, the committee will discuss NDA 206317, ferric pyrophosphate solution, for administration via hemodialysis dialysate, application submitted by Rockwell Medical, Inc. The proposed indications (uses) for this product are for the treatment of iron loss or iron deficiency to maintain hemoglobin in adult patients with hemodialysis-dependent stage 5 chronic kidney disease (CKD 5HD) and to reduce the prescribed dose of erythropoiesis stimulating agent (ESA) required to maintain desired hemoglobin levels.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 11/14/14-11/14/14

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Meeting Details:

On November 14, 2014, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the AcrySof® IQ ReSTOR® Multifocal Toric Posterior Chamber Intraocular Lens submitted by applicant Alcon Laboratories, Inc. This intraocular lens combines the optical properties of a +3 diopter multifocal intraocular lens with the optical properties of a toric intraocular lens. The proposed indication for use is: The AcrySof® IQ ReSTOR® Multifocal Toric Posterior Chamber Intraocular Lens (IOL) are intended for primary implantation for the visual correction of aphakia and pre-existing astigmatism secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual refractive cylinder, and increased spectacle independence. The lens is intended to be placed in the capsular bag.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm

Meeting Date: 11/24/14-11/25/14

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Meeting Details:

The committee will discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management. The committee will also consider the efficacy of ESI and the overall risk benefit balance of injecting steroids in the epidural space to treat pain. These considerations will assist the Agency in our discussions of possible regulatory options, including but not limited to changes to the product labeling.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drug AdComm

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

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

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

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Meeting Details:

On December 12, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Superion InterSpinous Spacer device sponsored by Vertiflex Incorporated. The proposed Indication for Use for the Superion InterSpinous Spacer device, as stated in the PMA, is as follows: the Superion InterSpinous Spacer (the Superion ISS) is intended to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate lumbar spinal stenosis, with or without Grade 1 spondylolisthesis, confirmed by X-ray, MRI and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. The Superion ISS is indicated for those patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, numbness, and/or cramping, with or without back pain. The Superion ISS may be implanted at one or two adjacent lumbar (L) levels in patients in whom treatment is indicated at no more than two levels, from L1 to L5.

 

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

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 10/30/14-10/30/14

Meeting Details:

The committee will discuss new drug application (NDA) 206316, edoxaban tablets, submitted by Daiichi Sankyo, Inc., for the prevention of stroke and systemic embolism (blood clots other than in the head) in patients with nonvalvular atrial fibrillation (A Fib; abnormally rapid and chaotic contractions of the atria, the upper chambers of the heart).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 10/21/14-10/21/14

Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 203188, ivacaftor oral tablets, submitted by Vertex Pharmaceuticals Inc., for the treatment of cystic fibrosis in patients with an R117H mutation in the cystic fibrosis transmembrane conductance regulator gene.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 10/20/14-10/20/14

Meeting Details:

The committee will discuss biologics license application (BLA) 125504, secukinumab, a human monoclonal antibody, submitted by Novartis, proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Psychopharmacologic Drugs & DSRM

Meeting Date: 10/16/14-10/16/14

Meeting Details:

The committees will discuss the risk of serious neuropsychiatric adverse events with CHANTIX (varenicline tartrate) tablets, NDA 21928, Pfizer, Inc., and discuss options for addressing this risk.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 10/8/14-10/9/14

Meeting Details:

On October 8, the committee will discuss, make recommendations and vote on information related to the premarket approval application regarding the Boston Scientific Corporation’s WATCHMAN Left Atrial Appendage (LAA) Closure Technology. FDA is seeking committee review and recommendations regarding new clinical data and associated additional adverse events including stroke that have become available since the previous advisory committee meeting on the WATCHMAN device, which was held December 11, 2013. The WATCHMAN LAA Closure Technology is a percutaneously delivered permanent cardiac implant placed in the left atrial appendage. This device is indicated to prevent thromboembolism (TE) from the left atrial appendage. It may be considered for use in patients with non-valvular atrial fibrillation who are eligible for warfarin therapy to reduce the risk of stroke and systemic embolism based on CHADS2 (congestive heart failure, hypertension, age >75 years, diabetes, and prior stroke or transient ischemic attack (TIA)) or CHA2DS2-VASc (congestive heart failure, hypertension, age >75 years, diabetes mellitus, stroke/TIA/TE, vascular disease, age 65-74, and sex category) scores. On October 9, the committee will discuss and make recommendations regarding the classification of more-than-minimally manipulated allograft heart valves (MMM Allograft HVs). A MMM Allograft HV is a human valve or valved conduit that has been aseptically recovered from qualified donors, dissected free from the human heart, and then subjected to a manufacturing process(es) that alters the original relevant characteristics of the tissue (21 CFR 1271.3(f), 21 CFR 1271.10(a)(1), and 21 CFR 1271.20). The valve is then stored until needed by a recipient. An example of such a manufacturing process is one that intentionally removes the cells and cellular debris with the goal of reducing in vivo antigenicity. MMM Allograft HVs are considered preamendment devices because they were found substantially equivalent to devices in commercial distribution prior to May 28, 1976, when the Medical Device Amendments became effective. MMM Allograft HVs are currently regulated under Product Code OHA, ‘‘Heart Valve, More than Minimally Manipulated Allograft,’’ as unclassified devices and reviewed under the premarket notification, 510(k), authority (21 CFR part 807). FDA is seeking committee input on the safety and effectiveness of MMM Allograft HVs and the regulatory classification for MMM Allograft HVs.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 10/1/14-10/1/14

Meeting Details:

On October 1, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the SONABLATE 450 device sponsored by SonaCare Medical, LLC. The proposed Indication for Use for the SONABLATE 450 device, as stated in the PMA, is as follows: The SONABLATE 450 (SONABLATE) is intended for use in the treatment of localized, clinically recurrent prostate cancer after failure of primary external beam radiation therapy.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Past Meetings

Below is a listing of all committees. Select a committee to display all meetings available for that committee.

Live Meetings

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