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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic & Analgesic & DSRM Drug Adcomm

Meeting Date: 10/5/16-10/5/16

Meeting Details:

The committees will be asked to discuss naloxone products intended for use in the community, specifically the most appropriate dose or doses of naloxone to reverse the effects of life-threatening opioid overdose in all ages, and the role of having multiple doses available in this setting. The committees will also be asked to discuss the criteria prescribers will use to select the most appropriate dose in advance of an opioid overdose event and the labeling to inform this decision, if multiple doses are available.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic and Analgesic Drug Products AdComm and the DSRM AdComm

Meeting Date: 6/8/16-6/8/16

Meeting Details:

The committees will be asked to discuss new drug application (NDA) 207621, oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules, submitted by Pfizer, Inc., with the proposed indication of management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is an extended-release formulation intended to have abuse-deterrent properties based on the presence of naltrexone, an opioid antagonist, in the formulation. The committees will be asked to discuss whether the data submitted by the Applicant are sufficient to support labeling of the product with the properties expected to deter abuse.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 9:30AM-2:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic and Analgesic Drug Products AdComm and the DSRM AdComm

Meeting Date: 6/7/16-6/7/16

Meeting Details:

The committees will be asked to discuss new drug application (NDA) 207975, hydrocodone bitartrate extended-release tablets, submitted by Teva Branded Pharmaceutical Products R&D, Inc., with the proposed indication of management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is an extended-release formulation intended to have abusedeterrent properties based on its physicochemical properties. The committees will be asked to discuss whether the data submitted by the Applicant are sufficient to support labeling of the product with the properties expected to deter abuse.

 

       
Location: TBD Related News Links: Not Available
Time: 9:30AM-4:00PM    
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    
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Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

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

Meeting Details:

On March 3, 2014, the Pediatric Advisory Committee (PAC) will meet to discuss pediatric focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107–109) and the Pediatric Research Equity Act (Pub. L. 108–155). The PAC will meet to discuss ACTIVA Dystonia Therapy, ADVATE [Antihemophilic Factor (Recombinant)], FAMVIR (famciclovir), INTELENCE (etravirine), KEPPRA (levetiracetam), MAXALT and MAXALT MLT (rizatriptan), NATAZIA (estradiol valerate and estradiol valerate/dienogest), PERTZYE (pancrelipase), PREZISTA (darunavir), REYATAZ (atazanavir), SKLICE (ivermectin), TISSEEL (Fibrin Sealant), TORISEL (temsirolimus), ULTRESA (pancrelipase), Vertical Expandable Prosthetic Titanium Rib (VEPTR), VIREAD (tenofovir disoproxil fumarate).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsRisk Communications AdComm

Meeting Date: 12/17/13-12/17/13

Meeting Details:

On December 17, 2013, the Committee will meet to identify and discuss new methods for communicating risk information as part of Risk Evaluation and Mitigation Strategies (REMS) to health care providers. The discussion will also address how sponsors and FDA can evaluate whether REMS communications are reaching the targeted population, are increasing awareness and understanding of the key risk messages, as well as whether the communications are having the intended impact on knowledge, behaviors, and/or outcomes

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsTest Meeting

Meeting Date: 8/1/13-8/1/13

Meeting Details:

Test for BAi

 

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

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

Meeting Date: 10/13/11-10/13/11

Meeting Details:

On October 13, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application (PMA) for the Cook, Inc., ZILVER-PTX Drug-Eluting Stent. The ZILVER-PTX Stent is a self-expanding nitinol stent coated on its outer surface with the cytotoxic drug paclitaxel without any polymer, binder, or excipient at a dose density of 3 micrograms/square millimeter. The ZILVER-PTX Stent is available in diameters ranging from 5 to 10 millimeters (mm) and lengths of 20 to 80 mm and are pre-loaded onto 6 or 7 Fr \1\ (diameter of 2 or 2.3 mm) delivery systems. Upon deployment, the ZILVER-PTX Stent expands to establish and maintain patency in the stented region. The proposed indications for use are: treatment of de novo or restenotic symptomatic vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameter from 4 mm to 9 mm and total lesion lengths per patient of 280 mm.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting Announcement

Meeting Date: 7/27/11-7/27/11

Meeting Details:

The committee will discuss current strategies for the FDA’s Office of Pharmaceutical Science (OPS) implementation of Quality by Design (QbD) principles within its review offices, incorporating an update on the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) activities. The committee will also receive awareness presentations on FDA's current partnering with the United States Pharmacopeia (USP), principally to discuss the Monograph Modernization Program.

 

       
Location: White Oak Campus Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAllergenic Products AdComm

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

Meeting Details:

On May 12, 2011, in open session, the committee will receive updates and have discussion on the following topics: (1) Structure and Activities of the Laboratory of Immunobiochemistry (the Laboratory), Division of Bacterial, Parasitic, and Allergenic Products, Center for Biologics Evaluation and Research, FDA; (2) enzyme-linked immunosorbent assay replacement of radial immunodiffusion assays for potency determinations of cat and ragweed pollen allergen extracts by the Laboratory; (3) statistical considerations for the design and interpretation of phase III clinical trials of allergenic products; (4) environmental exposure chambers for phase III studies of allergenic products, and (5) International Organization for Standardization (ISO) 17025 accreditation of the Laboratory.

 

       
Location: Bethesda Doubletree Hotel Bethesda, MD 20814 Related News Links: Not Available
Time: 8:00AM-3:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsTest1

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

Meeting Details:

Test1

 

       
Location: Test1 Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsTest2

Meeting Date: 1/29/10-1/30/10

Meeting Details:

Test2

 

       
Location: Test2 Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsTest3

Meeting Date: 1/11/10-1/13/10

Meeting Details:

test3

 

       
Location: Test3 Related News Links: Not Available
Time: 9:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAllergenic Products AdComm

Meeting Date: 9/13/06-9/13/06

Meeting Details:

On September 13, 2006, the committee will discuss a proposed strategy for the reclassification of Category IIIA allergenic products. The committee will also receive an update of the research program of the Laboratory of Immunobiochemistry, Division of Bacterial, Parasitic and Allergenic Products, Center for Biologics Evaluation and Research.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 12:00PM-3:45PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAllergenic Products Advisory Committee

Meeting Date: 4/7/05-4/7/05

Meeting Details:

The Committee will discuss a proposed strategy for the reclassification of Class IIIA allergenic products. The Committee will also receive an update of the FDA Critical Path Initiative.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAllergenic Products Advisory Committee

Meeting Date: 3/15/02-3/15/02

Meeting Details:

On March 15, 2002, the committee will hear updates on: personnel and lot release activities of the Laboratory of Immunobiochemistry (LIB), LIB research programs, particulates in allergen extracts, reduction of possible risk of exposure to TSE agents in allergen extracts, and the statistical power of clinical studies used to assess bioequivalence of allergen extracts. The committee will discuss: considerations for the regulation of recombinant allergens for the diagnosis and treatment of allergic disease, and glycerol in allergen extracts.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAllergenic Products Advisory Committee

Meeting Date: 3/5/01-3/5/01

Meeting Details:

On March 5, 2001, the committee will hear updates on: Laboratory of Immunobiochemistry personnel, lot release statistics, new guidance documents, research and standardization programs, and a compliance report. The committee will discuss whether master seed stocks of mold strains used for allergenic extracts should be rederived to reduce a theoretical risk of TSE transmission. The committee will also discuss the statistical power of clinical studies used to assess bioequivalence as it applies to allergen extract studies. In the afternoon the committee will discuss particulates that appear in allergen extracts and the effect of these particulates on the safety and efficacy on these products. In closed session the committee will receive a report on the status of an IND and PLA supplement.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAllergenic Products

Meeting Date: 2/10/00-2/10/00

Meeting Details:

The committee will receive an update on the organizational changes of the Laboratory of Immunobiochemistry (LIB), it's regulatory activities (including reference replacements and lot release statistics) and its research activities. The committee will hear presentations and discuss the following regulatory issues: potency limits for standardized allergen vaccines, selection of allergen extracts for standardization and a proposed algorithm for the standardization of new allergens.

 

       
Location: Holiday Inn-Bethesda, Versailles Ballrooms I & II, Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAllergenic Products

Meeting Date: 2/22/99-2/22/99

Meeting Details:

The committee will discuss the current organization and the research programs of the Laboratory of Immunobiochemistry in the Division of Allergenic Products and Parasitology, OVRR. The committee will also discuss regulatory proposals concerning the potency limits for standardized allergen vaccines, requirements for protein content of these vaccines, modifications of the competitive ELISA assay, proposed package insert for allergen extracts, issues regarding use of pure allergens versus U.S. Standards, and an update on the status of Class IIIA allergen extracts.

 

       
Location: Holiday Inn-Bethesda Versailles Ballrooms I and Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Upcoming Meetings

Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsBone, Reproductive and Urologic Drugs Advisory Committee

Meeting Date: 12/6/16-12/6/16

Meeting Details:

The committee will discuss appropriate clinical trial design features, including acceptable endpoints for demonstrating clinical benefit, for drugs intended to treat secondary hypogonadism while preserving or improving testicular function, including spermatogenesis.

 

       
Location: Tommy Douglas Conference Center Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee Meeting

Meeting Date: 11/17/16-11/18/16

Meeting Details:

On the morning of November 17, 2016, the Committee will meet in open session to discuss strategies to manage iron deficiency associated with blood donation. The Committee will also discuss proposed procedures for assuring donor safety for collections of blood from female donors with hemoglobin values of 12.0-12.4g/dL or a hematocrit value between 36 and 38. In the afternoon, the Committee will meet in open session to discuss adverse reactions related to blood donation in teenage (16 to 18 years) donors, and the effectiveness of several mitigation measures. On November 18, 2016, the Committee will meet in open session to hear an informational session on Zika virus and blood safety in the United States. Following the informational session, the Committee will hear presentations on the following topics: (1) The Transfusion Transmissible Infections Monitoring System; (2) a summary of the FDA workshop on new methods to predict the immunogenicity of therapeutic coagulation proteins; and (3) a summary of the FDA workshop on preclinical evaluation of red blood cells for transfusion.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMicrobiology Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 11/9/16-11/10/16

Meeting Details:

On November 9, 2016, during session one, the committee will discuss and make recommendations regarding the reclassification of quantitative Cytomegalovirus (CMV) viral load devices from class III (Premarket approval) to class II (510(k)). A nucleic acid-based in vitro diagnostic device for the quantitation of CMV viral load, within the context of transplant patient management, is a post-amendment device classified into class III under section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act )(21 U.S.C. 360c(f)(1). To date, the following product code has been established for CMV viral load devices: PAB (CMV DNA Quantitative Assay). During session two, the committee will discuss and make recommendations regarding the appropriate initial classification for qualitative or quantitative viral load devices for Epstein-Barr virus, BK virus, JC virus, Human Herpesvirus 6, and Adenovirus infections. FDA is seeking expert recommendations to assess the potential risks and benefits of these devices when used in patients following solid-organ or stem cell transplantation.

 

       
Location: Gaithersburg Holiday Inn 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.

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