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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting Postponed: Immunology Devices Panel

Meeting Date: 10/14/11-10/14/11

Meeting Details:

On October 14, 2011, the committee will discuss, make recommendations, and vote on a premarket approval application for the Progensa PCA3 assay sponsored by Gen-Probe, Inc. The Progensa PCA3 assay is indicated for use in conjunction with other patient information to aid in the decision for repeat biopsy in men 50 years of age or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended based on current standard of care, before consideration of PCA3 assay results. A lower PCA3 score is associated with a decreased likelihood of a positive biopsy.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsImmunology Devices Panel

Meeting Date: 12/3/08-12/3/08

Meeting Details:

The committee will discuss and make recommendations on the premarket notification application for the Fujirebio HE4 EIA kit and associated Risk of Malignancy algorithm (ROMA\TM\) Test. The HE4 EIA is an enzyme immunometric assay for the quantitative determination of HE4 in human serum. The HE4 EIA, used in conjunction with the ARCHITECT CA 125 II assay, creates a predictive probability of epithelial ovarian cancer using a mathematical function referred to as the ROMA\TM\, for use in premenopausal and postmenopausal women presenting with an adnexal mass who have already been referred to an oncologic specialist and are scheduled for surgery. Subjects categorized as low risk for epithelial ovarian cancer using the ROMA\TM\ value may have surgical intervention performed by a non-oncology specialist. The results must be interpreted in conjunction with other clinical findings in accordance with standard clinical management guidelines. The assay is not indicated as an aid in a decision to proceed to surgery.

 

       
Location: Hilton Washington DC North/Gaithersburg Gaithersburg, MD. Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsImmunology Devices Panel

Meeting Date: 11/16/06-11/16/06

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a laboratory assay designed for the rapid detection of clinically relevant (greater than 0.2 millimeters) metastases in lymph node tissue removed from breast cancer patients. Results from the assay can be used to guide the surgeon’s decision to excise additional lymph nodes and aid in staging.

 

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

Meeting Date: 7/15/05-7/15/05

Meeting Details:

The committee will hear a presentation on the FDA Critical Path Initiative and a presentation by the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health outlining their responsibility for the review of postmarket study design. The committee will also discuss, make recommendations, and vote on a premarket approval application for a laboratory assay designed to measure levels of neural thread protein in urine specimens from patients presenting with cognitive complaints or other signs and symptoms of suspected Alzheimer’s disease. Results from this test are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, to aid the physician in the differential diagnosis of Alzheimer’s disease.

 

       
Location: HOL - Bethesda Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsImmunology Devices

Meeting Date: 12/13/99-12/13/99

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an enzyme immunoassay (EIA) to be used as an aid in the diagnosis of patients with transitional cell carcinoma of the urinary tract.

 

       
Location: Corporate Bldg. Rockville, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsImmunology Devices Panel

Meeting Date: 11/9/98-11/9/98

Meeting Details:

The committee will discuss, make recommendations, and vote on apremarket approval application (PMA) for a fluorescence in situ hybridization(FISH) assay used in the detection of amplification of the HER-2/neu gene from subjects with node positive, stage II breast cancer to aid in the assessment of response to adjuvant therapy.

 

       
Location: FDA Corporate Building, Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs Advisory Committee

Meeting Date: 3/30/95-3/31/95

Meeting Details:

On March 30, 1995, the subcommittee will discuss data relevant to NDA 20-513 (250 milligrams (mg) capsules) and NDA 20-514 (500 mg tablets), for mycophenolate mofetil (CellCept, Syntex Laboratories, Inc.), for use in the prophylaxis of organ rejection and treatment of refractory organ rejection in patients receiving allergenic renal transplants. On March 31, 1995, the subcommittee will discuss data relevant to NDA 50-715 (soft gelatin capsules) and NDA 50-716 (oral solution) for cyclosporine microemulsion (Neoral, Sandoz Pharmaceuticals Corp.) for prophylaxis of organ rejection in kidney, liver, and heart allergenic transplants.

 

       
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 of the Medical Devices AdComm

Meeting Date: 2/23/17-2/23/17

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Meeting Details:

On February 23, 2017, the committee will discuss and make recommendations on clinical information related to the de novo request for the Sentinel® Cerebral Protection System, a first of a kind embolic protection device to be used with transcatheter aortic valve replacement (TAVR) procedures.

 

       
Location: Hilton Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee Meeting

Meeting Date: 3/6/17-3/7/17

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Meeting Details:

On Monday, March 6, 2017, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by The Food and Drug Administration Safety and Innovation Act (FDASIA), for NITROPRESS (sodium nitroprusside), KUVAN (sapropterin dihydrochloride) and TRUVADA (emtricitabine/tenofovir disoproxil fumarate). On Tuesday, March 7, 2017, as mandated by the Food and Drug Administration Amendments Act, Title III, Pediatric Medical Device Safety and Improvement Act of 2007 (Public Law 110– 85), the committee will discuss the safety of and the ongoing propriety of the humanitarian device exemption for: EPICEL (cultured epidermal autografts) (HDE), IMPELLA RP SYSTEM (HDE), LIPOSORBER LA-15 SYSTEM (HDE), MEDTRONIC ACTIVA DYSTONIA THERAPY (HDE).

 

       
Location: tbd Related News Links: Not Available
Time: 8:30AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory Committee

Meeting Date: 3/9/17-3/9/17

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Meeting Details:

On March 9, 2017, 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 2017-2018 influenza season.

 

       
Location: National Institutes of Health (NIH) Fishers Lane Conference Center (T-Terrace Level) 5635 Fishers Lane Rockville, MD 20852-1722 Related News Links: Not Available
Time: 8:30AM-3:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the DSRM AdComm and the Anesthetic and Analgesic Drug Products AdComm

Meeting Date: 3/13/17-3/14/17

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Meeting Details:

The committees will be asked to discuss safety issues for new drug application (NDA) 201655, OPANA ER (oxymorphone hydrochloride) Extended-release Tablets, by Endo Pharmaceuticals Inc., with the 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 approved extended-release (ER) formulation intended to have abuse-deterrent properties based on its physicochemical properties, however, this information is not currently reflected in product labeling. The committees will be asked to discuss pre- and post-marketing data about the abuse of OPANA ER, and the overall risk-benefit of this product. The committees will also discuss abuse of generic oxymorphone ER and oxymorphone immediate-release (IR) products.

 

       
Location: tbd Related News Links: Not Available
Time: 9:15AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology AdComm

Meeting Date: 3/15/17-3/15/17

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Meeting Details:

The use of model-informed drug development (MIDD) for new and generic drugs has significantly increased over the past several years. The committee will discuss strategies, approaches, and challenges in MIDD with specific focus on two areas. During the morning session, the committee will discuss approaches and evidentiary information needed for applying physiologically-based pharmacokinetic modeling and simulation throughout a drug’s lifecycle. During the afternoon session, the committee will discuss mechanistic model-informed safety evaluation with a focus on drug potential for causing arrhythmias. The Comprehensive in Vitro Proarrhythmia Assay will be discussed as an exemplar.

 

       
Location: Omni Shoreham Hotel The Ballroom 2500 Calvert Street, NW Washington, DC 20008 Related News Links: Not Available
Time: 7:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Ophthalmic Devices Panel of the Medical Devices AdComm and the RC AdComm

Meeting Date: 3/17/17-3/17/17

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Meeting Details:

On March 17, 2017, the committee will discuss and make recommendations regarding the potential risks of misuse of peroxide-based contact lens products.  Specific issues to be discussed include adequate labeling and packaging of these over-the-counter products.

 

       
Location: tbd Related News Links: Not Available
Time: 7:30AM-4:00PM    
Materials:
   
       

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