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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 OptionsAntimicrobial Drugs AdComm

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

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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    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology AdComm

Meeting Date: 5/7/19-5/7/19

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Meeting Details:

The committee will discuss the following topics: (1) Approaches to evaluate the effect of renal impairment on drug exposure, and (2) best practice considerations for translating pharmacokinetic (PK) information into dose individualization instructions. Regarding topic 1, many registration trials exclude patients with advanced kidney disease, and product labeling dosing instructions for these patients are commonly derived from our understanding of the change in the PK in individuals with varying degrees of renal function. The most common current approach to determine dosing instructions for patients with varying degrees of renal function begins with a stand-alone renal impairment study, either full design or reduced design. In addition to stand-alone renal impairment studies, drug development programs often use the findings from population PK (POPPK) analyses, which leverage the PK information across all the studies available in a drug development program. An alternative approach to consider is for drug development programs to predict the impact of renal impairment on the PK of the drug, either based on the understanding of the PK of a new molecular entity or using physiologic based PK (PBPK) models, without a stand-alone renal impairment study. Patients with impaired renal function can then be included in later stage clinical trials, with prospective dose adjustment incorporated if deemed necessary based the predictions. The dosing should be confirmed based on analysis of PK samples from the late stage trials (sparse PK, POPPK analysis). Regarding topic 2, dose individualization is typically achieved by applying the concept of `exposure-matching' under the assumption that such a maneuver will result in a benefit-risk similar to that observed in the registration trials. The committee will discuss the application of `exposure matching,' including the necessary assumptions and any limitations.

 

       
Location: TBA Related News Links: Not Available
Time: 9:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 5/8/19-5/8/19

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Meeting Details:

The committee will discuss new drug application (NDA) 202049, for mannitol inhalation powder, for oral inhalation submitted by Chiesi USA, Inc., for the proposed indication of management of cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction with standard therapies.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 5/14/19-5/14/19

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Meeting Details:

During the morning session, the committee will discuss new drug application (NDA) 211810 for pexidartinib capsule, submitted by Daiichi Sankyo, Inc. The proposed indication (use) for this product is for the treatment of adult patients with symptomatic tenosynovial giant cell tumor, also referred to as giant cell tumor of the tendon sheath or pigmented villonodular synovitis, which is associated with severe morbidity or functional limitations, and which is not amenable to improvement with surgery. During the afternoon session, the committee will discuss NDA 212166 for quizartinib tablets, submitted by Daiichi Sankyo, Inc. The proposed indication (use) for this product is for the treatment of adults with relapsed or refractory acute myeloid leukemia, which is FLT3-ITD positive, as detected by an FDA-approved test.

 

       
Location: TBA 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: 6/19/19-6/20/19

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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    
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Recent Meetings

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    
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Meeting OptionsMeeting OptionsMeeting OptionsCancelled - Pulmonary-Allergy Drugs AdComm

Meeting Date: 3/27/19-3/27/19

Meeting Details:

The committee will discuss new drug application (NDA) 208646, submitted by AllerQuest, LLC, for a skin-test kit (proposed trade name PRE-PEN Plus) that combines the approved product PRE-PEN (benzylpenicilloyl polylysine for injection) with penicillin G potassium, penicilloic acid, penilloic acid, and amoxicillin sodium, for the proposed indication to detect IgE sensitization to penicillin antigens and reliably rule out the potential for immediate life- threatening penicillin allergic reactions with a high degree of probability in patients with history of possible IgE-dependent penicillin allergy. The discussion will include study design considerations, the contribution of each of the components, and whether the submitted data provide substantial evidence of efficacy.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 3/25/19-3/26/19

Meeting Details:

On March 25 and 26, 2019, the committee will discuss and make recommendations regarding the benefits and risks of breast implants indicated for breast augmentation and reconstruction concerning the following topics: (1) breast implant associated anaplastic large cell lymphoma (BIA-ALCL); (2) systemic symptoms reported in patients receiving breast implants; (3) the use of registries for breast implant surveillance; (4) magnetic resonance imaging screening for silent rupture of silicone gel filled breast implants; (5) the use of surgical mesh in breast procedures such as breast reconstruction and mastopexy; (6) the use of real-world data and patient perspectives in regulatory decision making, and (7) best practices for informed consent discussions between patients and clinicians.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Past Meetings

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