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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Analgesic with DSRM AdComm

Meeting Date: 7/26/17-7/26/17

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Meeting Details:

The committees will discuss new drug application (NDA) 209653, for oxycodone hydrochloride extended-release oral tablets, submitted by Intellipharmaceutics Corp., with the proposed indication of management of moderate-to-severe pain when a continuous around the clock analgesic is needed for an extended period of time. The product has been formulated with properties intended to deter abuse, and the applicant has submitted data to support these abuse-deterrent properties for this product. The committees will be asked to discuss the overall risk-benefit profile of the product, and whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 7/28/17-7/28/17

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Meeting Details:

On July 28, 2017, the Vaccines and Related Biological Products Committee (VRBPAC) will meet in an open session to discuss and make recommendations on the safety and efficacy of a Hepatitis B Vaccine manufactured by Dynavax.

 

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

Meeting Date: 8/2/17-8/2/17

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Meeting Details:

The committee will discuss biologics license application (BLA) 761057, for sirukumab injection (proposed trade name PLIVENSIA), submitted by Janssen Biotech, Inc., for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs. The discussion will include dose selection, efficacy, radiographic progression study, and safety.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 7/11/17-7/13/17

Meeting Details:

- DAY 1: - The committee will discuss biologics license application (BLA) 761060, MYLOTARG (gemtuzumab ozogamicin) for intravenous use, submitted by Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. The proposed indication (use) for this product is in combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of adult patients with previously untreated, de novo acute myeloid leukemia (AML). - DAY 2: - The committee will discuss biologics license application (BLA) 125646 for tisagenlecleucel-T suspension for intravenous use. The application was submitted by Novartis Pharmaceuticals Corp. The proposed indication (use) for this product is for the treatment of pediatric and young adult patients 3 to 25 years of age with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). - DAY 3: - During the morning session, the committee will discuss biologics license application (BLA) 761028 for ABP 215, a proposed biosimilar to Genentech/Roche’s AVASTIN (bevacizumab), submitted by Amgen Inc. The proposed indications/uses for this product are: (1) For the first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with intravenous 5-fluorouracil-based chemotherapy; (2) in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line ABP 215-containing regimen; (3) for the first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel; (4) for the treatment of glioblastoma with progressive disease in adult patients following prior therapy as a single agent; (5) for the treatment of metastatic renal cell carcinoma in combination with interferon alfa; and (6) in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of persistent, recurrent, or metastatic carcinoma of the cervix. During the afternoon session, the committee will discuss biologics license application (BLA) 761074 for MYL-1401O, a proposed biosimilar to Genentech Inc.’s HERCEPTIN (trastuzumab), submitted by Mylan GmbH. The proposed indications/uses for this product are: (1) For adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer; (a) as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; (b) with docetaxel and carboplatin; or (c) as a single agent following multi-modality anthracycline based therapy; (2) in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer; (3) as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease; and (4) in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee

Meeting Date: 6/21/17-6/22/17

Meeting Details:

On June 21, 2017, information will be presented to gauge investigator interest in exploring potential pediatric development plans for three products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) APX-005M, presentation by Apexigen, Inc.; (2) PMO1183 (lurbinectedin), presentation by PharmaMar USA Inc.; and (3) ASP2215 (gilteritinib), presentation by Astellas Pharma Global Development, Inc. On June 22, 2017, information will be presented to gauge investigator interest in exploring potential pediatric development plans for two products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) Prexasertib, presentation by Dista Products/Eli Lilly and Company and (2). olaratumab, presentation by Eli Lilly and Company.

 

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

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Past Meetings

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