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Past Meetings

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    
Materials:
   
       

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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    
Materials:
   
       

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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 OptionsNew Date: Orthopaedic and Rehabilitation Devices Panel

Meeting Date: 2/20/15-2/20/15

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Meeting Details:

On February 20, 2015, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Superion InterSpinous Spacer device sponsored by Vertiflex Incorporated. The proposed Indication for Use for the Superion InterSpinous Spacer device, as stated in the PMA, is as follows: the Superion InterSpinous Spacer (the Superion ISS) is intended to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate lumbar spinal stenosis, with or without Grade 1 spondylolisthesis, confirmed by X-ray, MRI and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. The Superion ISS is indicated for those patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, numbness, and/or cramping, with or without back pain. The Superion ISS may be implanted at one or two adjacent lumbar (L) levels in patients in whom treatment is indicated at no more than two levels, from L1 to L5.

 

       
Location: Hilton Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 2/24/15-2/24/15

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Meeting Details:

The committees will discuss new drug application (NDA) 203324, for riboflavin ophthalmic solutions with UV-A irradiation, submitted by Avedro, Inc. The combination products are used in corneal collagen cross-linking and proposed to be indicated for the treatment of progressive keratoconus or corneal ectasia following refractive surgery.

 

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

Meeting Date: 2/27/15-2/27/15

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Meeting Details:

On February 27, 2015, the committee will discuss, make recommendations and vote on information regarding the premarket approval application (PMA) panel-track supplement to expand the indication for use for the Radiesse Injectable Implant (Radiesse) device to include subdermal implantation for hand augmentation to correct volume deficit in the hands. The proposed indication for use for the Radiesse device, as stated in the PMA is as follows: The Radiesse device is for hand augmentation to correct volume deficit in the hands. FDA has previously approved the Radiesse device for the following two indications for use: The Radiesse device is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. It is also indicated for subdermal implantation for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. The Radiesse device remains unchanged from the current FDA approved version.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 3/4/15-3/4/15

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Meeting Details:

On March 4, 2015, from 8:30 a.m. to 3 p.m., the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2015-2016 influenza season.

 

       
Location: Hilton - Silver Spring, MD Related News Links: Not Available
Time: 8:30AM-3:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 3/9/15-3/9/15

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Meeting Details:

During the morning session, the committee will discuss new drug application (NDA) 206333, deoxycholic acid injection, a cytolytic drug, submitted by Kythera Biopharmaceuticals, proposed for the improvement in the appearance of moderate-to-severe convexity or fullness associated with submental fat in adults. During the afternoon session, the committee will discuss pediatric development of systemic products for the treatment of atopic dermatitis with inadequate response to topical prescription therapy.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs AdComm

Meeting Date: 1/22/15-1/22/15

Meeting Details:

The committee will discuss new drug applications (NDAs) 207-500 and 207-501, isavuconazonium sulfate capsules and isavuconazonium sulfate for injection, sponsored by Astellas Pharma Global Development, Inc., respectively for the proposed indications of treatment of invasive aspergillosis and mucormycosis.

 

       
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

Meeting Date: 1/12/15-1/12/15

Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 022517, proposed trade name NOCDURNA (established name: desmopressin), orally disintegrating sublingual tablets submitted by Ferring Pharmaceuticals, Inc. The proposed indication is treatment of nocturia due to nocturnal polyuria in adults who awaken two or more times each night to void.

 

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

Meeting Date: 1/7/15-1/7/15

Meeting Details:

The committee will discuss biologics license application (BLA) 125553 for EP2006, a proposed biosimilar to Amgen Inc.'s NEUPOGEN (filgrastim), submitted by Sandoz, Inc. The proposed indications (uses) for this product are: (1) To decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever; (2) for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with acute myeloid leukemia; (3) to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by marrow transplantation; (4) for the mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis; and (5) for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.

 

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

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Past Meetings

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