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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs AdComm

Meeting Date: 2/14/13-2/14/13

Meeting Details:

On February 14, 2013, the committee will discuss new drug application (NDA) 204781, proposed trade name DOTAREM (gadoterate meglumine injection), application submitted by Guerbet, LLC. The proposed indication (use) for this product is for magnetic resonance imaging in brain (intracranial), spine, and associated tissues in adults and pediatric patients (from neonates to 17 years of age) to detect and visualize areas with disruption of the blood brain barrier (specialized tissues that help protect the brain) and/or abnormal vascularity (abnormal blood circulation).

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-3:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs

Meeting Date: 7/10/00-7/10/00

Meeting Details:

The committee will discuss biologic license application (BLA) 99-1407, Leutech(Technicium labeled TC99M anti/CD15 antibody injection), Palatin Technologies, Inc., imaging agent as an aid in the diagnosis of equivocal appendicitis.

 

       
Location: Holiday Inn Bethesda, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs

Meeting Date: 6/28/99-6/29/99

Meeting Details:

Section 121 of the Food and Drug Administration Modernization Act of 1997 directs the Food and Drug Administration to establish appropriate procedures for the approval of positron emission tomography (PET) drugs under section 505 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355. At this meeting, FDA will present its findings on the safety and effectiveness of three PET drugs -- Fludeoxyglucose F 18 Injection, Ammonia N 13 Injection, and Water O 15 Injection for particular indications based on review of published literature. The committee will discuss the safety and effectiveness data on these three drugs. FDA also will discuss its proposed procedures for obtaining marketing approval for these three PET drugs. *** Call for Satellite, Videoconferencing and Webcasting ***

 

       
Location: Holiday Inn Two Montgomery Village Avenue Gaithe Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs

Meeting Date: 2/9/98-2/9/98

Meeting Details:

The commitee will discuss the safety and efficacy of new drug application (NDA) 20-887 AcuTectTM (Technetium Tc99m apcitide) for the detection and localization of acute venous thrombosis. The sponser is Diatide, Inc.

 

       
Location: Holiday Inn, Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs Advisory Committee

Meeting Date: 7/22/96-7/23/96

Meeting Details:

The committee will discuss the Center for Biologics Evaluation and Research's product license application 95- 0041 for Prostascint TM (Cytogen Corp.), a radiolabeled monoclonal antibody designed to detect sites of metastatic cancer which express the prostate specific membrane antigen.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs

Meeting Date: 2/15/96-2/16/96

Meeting Details:

The committee will discuss and begin drafting ``Points to Consider (PTC) for Developing Medical Imaging Agents.'' The purpose of the meeting is to provide the committee opportunity to work together on this draft and not primarily to hear presentations. The agents encompassed will include radiologic contrast media and nuclear medicine pharmaceuticals. The committee will discuss product license application (PLA) 91-0209, from Immunomedics, for Immu-4, a murine monoclonal antibody fragment directed against the carcinoembryonic antigen (CEA).

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs Advisory Committee

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

Meeting Details:

The committee will hold a preliminary discussion in preparation for drafting of future ``Points to Consider for Diagnostic Imaging Agents''.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 6/2/16-6/3/16

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Meeting Details:

On June 2 and 3, 2016, the committee will discuss recent reports and epidemiologic investigations of nontuberculous mycobacteria (NTM) infections associated with the use of heater-cooler devices during cardiac surgical procedures. FDA is convening this committee to seek expert scientific and clinical opinion related to contamination of heater-cooler devices, associated patient infections, and mitigation strategies based on available scientific information. The committee will make recommendations on: (1) the effectiveness of cleaning and disinfection methods for heater-cooler devices; (2) the amount and type of premarket data and information needed to demonstrate validation of cleaning and disinfection of heater-cooler devices in support of labeling claims and technical instructions; (3) appropriate risk mitigations to be implemented by manufacturers of heater-cooler devices and/or hospital facilities to ensure patient safety during surgical procedures where these devices are used; and (4) appropriate guidelines and/or criteria based on a risk stratification schema for notifying patients who may have already been exposed to NTM during prior cardiac surgeries. Recommendations on these issues will assist FDA in minimizing patient exposure to infections that may result from contaminated heater-cooler devices.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic and Analgesic Drug Products AdComm and the DSRM AdComm

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

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

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

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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    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs Advisory Committee

Meeting Date: 6/9/16-1/1/16

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Meeting Details:

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

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting-Anesthetic and Analgesic Drug Products AC, the DSRM AC, and the Pediatric AC

Meeting Date: 9/15/16-9/16/16

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Meeting Details:

The purpose of this public advisory committee meeting is to discuss the appropriate development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including obtaining pharmacokinetic data and the use of extrapolation.

 

       
Location: TBD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm (Sanofi Aventis)

Meeting Date: 5/25/16-5/25/16

Meeting Details:

The committee will discuss the safety and efficacy of new drug applications (NDAs) 208673 for insulin glargine and lixisenatide injection, a fixed ratio drug product consisting of insulin and a GLP-1 receptor agonist, and 208471 for lixisenatide injection, a GLP-1 receptor agonist, submitted by Sanofi Aventis c/o Sanofi U.S. Services Inc., proposed for the treatment of adults with type 2 diabetes mellitus.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm (Novo Nordisk)

Meeting Date: 5/24/16-5/24/16

Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 208583 for insulin degludec and liraglutide injection, submitted by Novo Nordisk Inc., for the proposed indication: adjunct to diet and exercise to improve glycemic control in the treatment of adults with type 2 diabetes mellitus.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 5/24/16-5/24/16

Meeting Details:

On May 24, 2016, the committee will discuss, make recommendations and vote on information related to the premarket approval application regarding St. Jude Medical’s AMPLATZER Patent Foramen Ovale (PFO) Occluder. The AMPLATZER PFO Occluder is a percutaneously delivered permanent cardiac implant for PFO closure. The device is indicated for preventing recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.

 

       
Location: Hiton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory Committee

Meeting Date: 5/11/16-5/11/16

Meeting Details:

On May 11, 2016, the committee will meet by teleconference. In open session, the committee will hear updates of the research program in the Laboratory of Bacterial Polysaccharides, Division of Bacterial, Parasitic, and Allergenic Products, Center for Biologics Evaluation and Research, FDA.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 1:00PM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm and the DSRM AdComm

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

Meeting Details:

On May 5, 2016, from 8:00 a.m. to 9:15 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)). During this session, the committees will discuss the drug development program of an investigational abuse-deterrent opioid product. The committees will be asked to discuss new drug application (NDA) 208653, benzhydrocodone/acetaminophen oral tablets, submitted by KemPharm, Inc., with the proposed indication of short-term (up to 14 days) management of acute pain. The product has been formulated with the intent to provide abuse-deterrent properties. Benzhydrocodone is a hydrocodone prodrug which, according to the applicant, is rapidly converted into hydrocodone by enzymes in the gastrointestinal tract. The active drugs in this fixed-dose combination are hydrocodone and acetaminophen. The applicant has submitted data to support abuse-deterrent properties for this product. The committees will be asked to discuss whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling, and whether the nasal route of abuse is relevant for combination products made up of hydrocodone and acetaminophen.

 

       
Location: tbd Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the DDSRM AdComm and the Anesthetic and Analgesic Drug Products AdComm

Meeting Date: 5/4/16-5/4/16

Meeting Details:

The Food and Drug Administration Amendments Act of 2007 (Public Law 110-85) requires FDA to bring, at least annually, one or more drugs with Risk Evaluation and Mitigation Strategies (REMS) with Elements to Assure Safe Use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On May 3 and 4, 2016, the committees will discuss results from assessments of the extended-release and long-acting (ER/LA) Opioid Analgesics REMS. The Agency will seek the committees’ comments as to whether this REMS with ETASU assures safe use, is not unduly burdensome to patient access to the drugs, and to the extent practicable, minimizes the burden to the healthcare delivery system.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs Advisory Committee

Meeting Date: 4/25/16-4/25/16

Meeting Details:

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

 

       
Location: College Park Marriott Hotel and Conference Center Chesapeake Ballroom 3501 University Boulevard East, Hyattsville, MD 20783 Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Past Meetings

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