FDALiveFDALive.com

The World's Leading Source for FDA Broadcasting

Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 4/25/19-4/26/19

Meeting Details:

Day 1 - On April 25th, The committee will discuss one or more possible pathways for approval of rabies virus monoclonal antibodies for use as the passive-immunization component of post-exposure prophylaxis. Day 2 - On April 26th, The committee will discuss the safety and effectiveness of bacitracin for intramuscular injection for the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug, which is the only approved indication for bacitracin for intramuscular injection. The committee will also consider whether there are other uses for bacitracin for intramuscular injection that could be studied. FDA will present background information on the regulatory history of bacitracin for intramuscular injection and information on the current use of bacitracin for intramuscular injection.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 4/8/19-4/8/19

Meeting Details:

On April 8, 2019, the PAC will meet to discuss drug development for testosterone replacement therapy in male adolescents for conditions associated with a deficiency or absence of endogenous testosterone resulting from structural or genetic etiologies ("classic hypogonadism"). The following topics will be considered for discussion: diagnosing male adolescents with classic hypogonadism, evidence to establish efficacy and safety of testosterone replacement therapy in this population, study design, and feasibility considerations for such studies. The committee will not discuss any individual research programs.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsJoint Arthritis & DSRM AdComm - Sponsor: Takeda Pharmaceuticals

Meeting Date: 1/11/19-1/11/19

Meeting Details:

The committees will discuss supplemental new drug application (sNDA) 021-856, ULORIC (febuxostat) tablets, sponsored by Takeda Pharmaceuticals, which includes the results from the postmarketing safety trial required by FDA to evaluate the cardiovascular safety of febuxostat, entitled “Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES).” Febuxostat is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout. The committees' discussion will include the results from the CARES trial, the benefit risk assessment of febuxostat, and potential regulatory actions.

 

       
Location: College Park Marriott Hotel Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsJoint Psychopharmacologic & DSRM AdComm - Sponsor: Alkermes Inc.

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

Meeting Details:

The committees will discuss efficacy, safety and risk-benefit profile of new drug application (NDA) 210417 for buprenorphine and samidorphan sublingual tablets, submitted by Alkermes, Inc., for adjunctive treatment of major depressive disorder.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology AdComm

Meeting Date: 9/20/18-9/20/18

Meeting Details:

The meeting will focus on two topics related to the Office of Pharmaceutical Quality’s priority of promoting the availability of better medicine. During the morning session, the committee will discuss the modernization of assessing drug applications through a Knowledge-Aided Assessment and Structured Application (KASA) initiative. FDA will seek input on the potential enhancement of a submission format consistent with KASA to improve the efficiency and consistency of regulatory quality assessment. During the afternoon session, the committee will discuss in-vitro/in-vivo relationship standards, and will seek input on establishing patient-focused dissolution standards for oral solid modified-release dosage forms.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

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

Meeting Details:

The committee will discuss new drug applications 209816, for omadacycline tablets, and 209817, for omadacycline injection, sponsored by Paratek Pharmaceuticals, Inc., for the proposed indications for the treatment of community acquired bacterial pneumonia and acute bacterial skin and skin structure infections.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-1:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 6/20/17-6/20/17

Meeting Details:

The committee will discuss a supplemental new drug application for VICTOZA (liraglutide) injection (sNDA 022341), sponsored by Novo Nordisk, for the proposed additional indication of: As an adjunct to standard treatment of cardiovascular risk factors to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and high cardiovascular risk.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 5/17/17-5/17/17

Meeting Details:

On May 17, 2017, the VRBPAC will meet in an open session to discuss considerations for evaluation of Respiratory Syncytial Virus vaccine candidates in seronegative infants.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-4:45PM    
Materials:
   
       

View Meeting Details / News

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

Meeting Date: 4/5/17-4/5/17

Meeting Details:

The committees will discuss new drug application (NDA) 209777, for oxycodone hydrochloride immediate-release oral tablets, submitted by Inspirion Delivery Sciences, LLC., with the proposed indication of management of moderate to severe pain where the use of an opioid analgesic is appropriate. The product has been formulated with properties intended to deter abuse, and the applicant has submitted data to support these abuse-deterrent properties for this product. The committees will be asked to discuss the overall risk-benefit profile of the product, and whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling.

 

       
Location: Tommy Douglas Conference Center Related News Links: Not Available
Time: 9:15AM-5:00PM    
Materials:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsArthritis Advisory Committee

Meeting Date: 7/25/19-7/25/19

.

Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 205832 for nintedanib capsules (drug name OFEV), sponsored by Boehringer Ingelheim, for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD). The focus of the discussion will be whether the application provides substantial evidence of efficacy for the proposed indication.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs AdComm

Meeting Date: 7/31/19-7/31/19

.

Meeting Details:

The committee will discuss new drug application (NDA) 209500, lumateperone tosylate capsules for oral administration, submitted by Intra-Cellular Therapies, Inc., for the treatment of schizophrenia.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting 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:
   
       

View Meeting Details / News

Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee of ODAC

Meeting Date: 6/20/19-6/20/19

Meeting Details:

During the morning session, the particular matter for this meeting will be review and discussion of the FDA Reauthorization Act of 2017 (FDARA) mandated Relevant Pediatric Molecular Target List now posted on the FDA website: https://www.fda.gov/?AboutFDA/?CentersOffices/?OfficeofMedicalProductsandTobacco/?OCE/?ucm544641.htm. FDA is required by statute to review and update the previously approved and published lists. The focus of the discussion will be limited to two target “classes” included in the Relevant Pediatric Molecular Target List: (1) Targets linked to cell lineage and (2) targets on normal immune cells and cells in the tumor microenvironment. Planned introductory presentations will be on: (1) Cell-based therapy approaches to childhood cancer and (2) novel membrane antigen determinants in pediatric tumors. During the afternoon session, information will be presented to gauge investigator interest in exploring potential pediatric development plans for two products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) ONC201, presentation by Oncoceutics Inc., and (2) CD24Fc, presentation by OncoImmune, Inc.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 6/19/19-6/20/19

Meeting Details:

On June 19 and 20, 2019, the committee will discuss and make recommendations on information related to recent observations of increased long-term mortality in peripheral arterial disease patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents compared to patients treated with uncoated comparator devices. FDA requests panel input regarding the presence and magnitude of the signal and potential causes. FDA also seeks input regarding appropriate regulatory actions associated with the findings.

 

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

View Meeting Details / News

Past Meetings

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

Live Meetings

There are no Live Broadcasts available at this time.