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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsEar, Nose, and Throat Devices Panel

Meeting Date: 4/30/15-5/1/15

Meeting Details:

On April 30, 2015, the committee will discuss and make recommendations regarding the classification of Hearing Protectors, Circumaural Hearing Protectors, Middle Ear Inflation Devices, Tactile Hearing Aid Devices, and Vestibular Analysis Apparatuses. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Hearing Protectors are currently regulated under the heading, “Protector, Hearing (Insert),” Product Code EWD, as unclassified under the 510(k) premarket notification authority. Circumaural Hearing Protectors are currently regulated under the heading, “Protector, Hearing (Circumaural),” Product Code EWE, as unclassified under the 510(k) premarket notification authority. Middle Ear Inflation Devices are currently regulated under the heading, “Device, Inflation, Middle Ear,” Product Code MJV, as unclassified under the 510k) premarket notification authority. Tactile Hearing Aid Devices are currently regulated under the heading, “Hearing Aid, Tactile,” Product Code LRA, as unclassified under the 510(k) premarket notification authority. Vestibular Analysis Apparatuses are currently regulated under the heading, “Apparatus, Vestibular Analysis,” Product Code LXV, as unclassified under the 510(k) premarket notification authority. FDA is seeking committee input on the risks, safety and effectiveness and the regulatory classification of Hearing Protectors, Circumaural Hearing Protectors, Middle Ear Inflation Devices, Tactile Hearing Aid Devices, and Vestibular Analysis Apparatuses. On May 1, 2015 the committee will discuss key issues related to a potential pre- to post-market shift in clinical data requirements for modifications to cochlear implants in pediatric patients. These issues are categorized into three broad areas for discussion: 1. Cochlear implant changes (e.g. sound processing features, patient characteristics) that may be suitable for this pre- to post-market shift in clinical data requirements. 2. Appropriate premarket clinical data requirements to support pre- to post-market shift (e.g. leveraging clinical data from adults and/or older children.) 3. Clinical study design considerations (e.g. study endpoints and test metrics, subject characteristics) for post market studies to confirm safety and effectiveness and inform future labeling.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEar, Nose and Throat Devices Panel

Meeting Date: 11/8/13-11/8/13

Meeting Details:

On November 8, 2013, the committee will discuss, make recommendations, and vote on information regarding the premarket approval (PMA) application for the Nucleus® Hybrid™ L24 Implant System sponsored by Cochlear Americas. The proposed Indication for Use for the Nucleus® Hybrid™ L24 Implant System (as stated in the PMA) is as follows: The Nucleus® Hybrid™ L24 Implant System is intended for patients aged 18 years and older who have residual low-frequency hearing sensitivity and bilateral severe to profound high frequency sensorineural hearing loss, and who obtain limited benefit from bilateral hearing aids.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEar, Nose, and Throat Devices Panel

Meeting Date: 12/18/09-12/18/09

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by Envoy Medical Corporation, for the Esteem Totally Implantable Hearing System. The ESTEEM is a totally implantable hearing device that is implanted in the middle ear to help hearing in patients suffering from mild to severe hearing loss that is sensorineural in origin. The Esteem System consists of three implantable components (Sound Processor, Sensor, and Driver), two external programmers (Esteem Programmer and Personal Programmer), an external Intraoperative System Analyzer (ISA) and accessories. The intended use of the ESTEEM is to alleviate hearing loss in adults by replicating the ossicular chain and providing additional gain. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.

 

       
Location: Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEar, Nose, and Throat Devices Panel

Meeting Date: 10/6/04-10/6/04

Meeting Details:

The committee will discuss general issues surrounding the prescription use versus over the counter (OTC) use of devices intended to treat snoring or mild to severe obstructive sleep apnea (OSA). The discussion will include the role of the medical/dental provider in the diagnosis, treatment and follow-up of snoring and OSA; the ability of the patient to self diagnose and treat OSA; the types of clinical data that would be needed to support an OTC intended use; and the components of adequate device labelling. The discussion will not include continuous positive airway pressure (CPAP) devices and surgical treatments for OSA.

 

       
Location: Gaithersburg , MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEar, Nose, and Throat Devices Panel

Meeting Date: 8/16/02-8/16/02

Meeting Details:

The committee will discuss and make recommendations on a draft guidance entitled “Implantable Middle Ear Hearing Device; Draft Guidance for Industry and FDA.” The topics for discussion will include the appropriate study population, objective measurement techniques for comparison of acoustic hearing aids and middle ear hearing devices, and subjective questionnaire development for determining postoperative effectiveness and quality of life outcome measures.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 12:30PM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEar, Nose and Throat Devices Panel

Meeting Date: 7/20/00-7/21/00

Meeting Details:

On July 20, 2000, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for a direct-drive implantable middle ear hearing device intended to provide a useful level of sound perception via mechanical stimulation of the ossicles. On July 21, 2000, the committee will discuss, make recommendations and vote on a PMA for an implant intended to restore useful hearing to individuals with Neurofibromatosis Type II who have become deaf as a result of surgery to remove bilateral auditory nerve tumors.

 

       
Location: Gaithersburg Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsThe Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 6/18/99-6/18/99

Meeting Details:

The committee will discuss generic issues relating to the safety and efficacy of middle ear amplification devices. *** Call for Satellite, Videoconferencing and Webcasting ***

 

       
Location: Corporate Bldg. Conference room 020B 9200 Corpor Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm (Novo Nordisk)

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

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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 OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

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

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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 OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm (Sanofi Aventis)

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

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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 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    
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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 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    
Materials:
   
       

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Past Meetings

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