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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs Advisory Committee

Meeting Date: 9/8/17-9/8/17

Meeting Details:

The committee will discuss the potential risk of gadolinium retention in the brain and other body organs in patients receiving gadolinium-based contrast agents for magnetic resonance clinical imaging procedures.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs AdComm

Meeting Date: 5/10/17-5/10/17

Meeting Details:

The committee will discuss new drug application (NDA) 208-630 for 5-Aminolevulinic Acid Hydrochloride [5-ALA HCl], Powder, for oral solution, submitted by NX Development Corp., for the proposed indication as an imaging agent to facilitate the real time detection and visualization of malignant tissue during glioma surgery.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs AdComm

Meeting Date: 2/14/13-2/14/13

Meeting Details:

On February 14, 2013, the committee will discuss new drug application (NDA) 204781, proposed trade name DOTAREM (gadoterate meglumine injection), application submitted by Guerbet, LLC. The proposed indication (use) for this product is for magnetic resonance imaging in brain (intracranial), spine, and associated tissues in adults and pediatric patients (from neonates to 17 years of age) to detect and visualize areas with disruption of the blood brain barrier (specialized tissues that help protect the brain) and/or abnormal vascularity (abnormal blood circulation).

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-3:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs

Meeting Date: 7/10/00-7/10/00

Meeting Details:

The committee will discuss biologic license application (BLA) 99-1407, Leutech(Technicium labeled TC99M anti/CD15 antibody injection), Palatin Technologies, Inc., imaging agent as an aid in the diagnosis of equivocal appendicitis.

 

       
Location: Holiday Inn Bethesda, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs

Meeting Date: 6/28/99-6/29/99

Meeting Details:

Section 121 of the Food and Drug Administration Modernization Act of 1997 directs the Food and Drug Administration to establish appropriate procedures for the approval of positron emission tomography (PET) drugs under section 505 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355. At this meeting, FDA will present its findings on the safety and effectiveness of three PET drugs -- Fludeoxyglucose F 18 Injection, Ammonia N 13 Injection, and Water O 15 Injection for particular indications based on review of published literature. The committee will discuss the safety and effectiveness data on these three drugs. FDA also will discuss its proposed procedures for obtaining marketing approval for these three PET drugs. *** Call for Satellite, Videoconferencing and Webcasting ***

 

       
Location: Holiday Inn Two Montgomery Village Avenue Gaithe Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs

Meeting Date: 2/9/98-2/9/98

Meeting Details:

The commitee will discuss the safety and efficacy of new drug application (NDA) 20-887 AcuTectTM (Technetium Tc99m apcitide) for the detection and localization of acute venous thrombosis. The sponser is Diatide, Inc.

 

       
Location: Holiday Inn, Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs Advisory Committee

Meeting Date: 7/22/96-7/23/96

Meeting Details:

The committee will discuss the Center for Biologics Evaluation and Research's product license application 95- 0041 for Prostascint TM (Cytogen Corp.), a radiolabeled monoclonal antibody designed to detect sites of metastatic cancer which express the prostate specific membrane antigen.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs

Meeting Date: 2/15/96-2/16/96

Meeting Details:

The committee will discuss and begin drafting ``Points to Consider (PTC) for Developing Medical Imaging Agents.'' The purpose of the meeting is to provide the committee opportunity to work together on this draft and not primarily to hear presentations. The agents encompassed will include radiologic contrast media and nuclear medicine pharmaceuticals. The committee will discuss product license application (PLA) 91-0209, from Immunomedics, for Immu-4, a murine monoclonal antibody fragment directed against the carcinoembryonic antigen (CEA).

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs Advisory Committee

Meeting Date: 10/26/95-10/26/95

Meeting Details:

The committee will hold a preliminary discussion in preparation for drafting of future ``Points to Consider for Diagnostic Imaging Agents''.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 4/2/20-4/3/20

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Meeting Details:

On April 2, 2020, in the morning, the BPAC will meet in open session to discuss and make recommendations on strategies to reduce the risk of Zika virus (ZIKV) transmission by blood and blood components. The committee will discuss whether universal testing of blood donations for ZIKV is an appropriate strategy considering the decline of ZIKV cases in the U.S. and worldwide. In the afternoon, the committee will meet in open session to hear an update on the Transfusion Transmissible Infections Monitoring System (TTIMS). Sponsored by the FDA, National Heart, Lung and Blood Institute and Office of the Assistant Secretary for Health, TTIMS collects incidence, prevalence and risk factor data for certain transfusion-transmitted infections, including HIV, in U.S. blood donations. On April 3, 2020, the committee will meet in open session to discuss and make recommendations on testing for hepatitis B surface antigen (HBsAg) in blood donations. The committee will discuss whether testing for HBsAg can be discontinued considering the sensitivity of hepatitis B virus nucleic acid testing and hepatitis B anti-core testing of blood donations in the U.S.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-3:45PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 4/21/20-4/21/20

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Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 209482/S-008, for TRELEGY ELLIPTA, a fixed dose combination (fluticasone furoate, umeclidinium, and vilanterol inhalation powder (FF/UMEC/VI)) oral inhalation, submitted by GlaxoSmithKline, for the following proposed labeling claim: Reduction in all-cause mortality in patients with chronic obstructive pulmonary disease (COPD). The focus of the discussion will be on the efficacy data submitted to support the proposed labeling claim, including the results from the Informing the Pathway of COPD Treatment (IMPACT) trial and the influence of inhaled corticosteroids (ICS) withdrawal on the results.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs Advisory Committee

Meeting Date: 4/23/20-4/23/20

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Meeting Details:

The committee will discuss new drug application 212123, flortaucipir F18 intravenous injection, a radioactive diagnostic agent, submitted by Avid Radiopharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, for positron emission tomography imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles of Alzheimer’s disease.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel of the Medical Devices AdComm

Meeting Date: 4/23/20-4/24/20

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Meeting Details:

On April 23, 2020, during session I, the committee will discuss and make recommendations regarding the classification of facet screws systems, which are currently unclassified pre-amendment devices to class II (general and special controls). During session II, the committee will discuss and make recommendations regarding the reclassification of noninvasive bone growth stimulators, which are currently post-amendment devices from class III (general controls and premarket approval) to class II (general and special controls). On April 24, 2020, the committee will discuss and make recommendations regarding the classification of three devices, which are currently unclassified pre-amendment devices to class II (general and special controls). The committee, during session I, will discuss semiconstrained toe (metatarsophalangeal) joint prostheses; during session II, will discuss intracompartmental pressure monitors; and during session III, will discuss intra-abdominal pressure monitoring devices.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 4/29/20-4/29/20

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Meeting Details:

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Location: tbd Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAllergenic Products Advisory Committee

Meeting Date: 5/15/20-5/15/20

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Meeting Details:

The Center for Biologics Evaluation and Research's (CBER) Allergenic Products Advisory Committee (APAC) will meet in open session to discuss and make recommendations on the safety and efficacy of Peanut (Arachis hypogaea) Allergen Extract manufactured by DBV Technologies, S.A for treatment of patients 4 through 11 years old with a confirmed diagnosis of peanut allergy.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-3:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs Advisory Committee

Meeting Date: 3/11/20-3/11/20

Meeting Details:

In the Agency's document entitled “Food Handler Antiseptic Drug Products for Over-the-Counter Human Use; Request for Data and Information” (December 7, 2018, 83 FR 63168) (Docket No. FDA-2018-N-3458), FDA sought input on the current use of over-the-counter antiseptics in the food handler setting and the recommended testing criteria to establish the safety and effectiveness of these products. Now that the comment period has closed, FDA plans to hold an advisory committee meeting to review the information submitted and discuss its key points.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 3/4/20-3/4/20

Meeting Details:

On March 4, 2020, under Topic I, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC 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 2020 to 2021 influenza season. Also, on March 4, 2020, under Topic II, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Respiratory and Special Pathogens (LRSP), Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, CBER.

 

       
Location: White Oak Related News Links: Not Available
Time: 8:30AM-5:10PM    
Materials:
   
       

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Past Meetings

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