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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsRisk Communication AdComm

Meeting Date: 3/5/18-3/6/18

Meeting Details:

Day 1 - The committee will discuss the impact of pregnancy and lactation labeling information in prescription drug and biological products as modified under the Pregnancy and Lactation Labeling Rule. The Pregnancy and Lactation Labeling Rule (PLLR) was implemented in June 2015, and required changes to labeling of information in prescription drug and biological products to better communicate clinically relevant information to health care providers on risks associated with medication exposure during pregnancy and lactation. The Agency seeks input and recommendations on: how information in PLLR labeling is being perceived and used by health care providers and other stakeholders, factors that are critical to health care providers’ interpretation of the data and counseling of pregnant women on the risks and benefits of a medication, and how to convey risk information to health care providers to accurately and adequately inform risk-benefit considerations for medication use during pregnancy. Day 2 - The committee will discuss the impact of pregnancy and lactation labeling information in prescription drug and biological products as modified under the Pregnancy and Lactation Labeling Rule. The Pregnancy and Lactation Labeling Rule (PLLR) was implemented in June 2015, and required changes to labeling of information in prescription drug and biological products to better communicate clinically relevant information to health care providers on risks associated with medication exposure during pregnancy and lactation. The Agency seeks input and recommendations on: how information in PLLR labeling is being perceived and used by health care providers and other stakeholders, factors that are critical to health care providers’ interpretation of the data and counseling of pregnant women on the risks and benefits of a medication, and how to convey risk information to health care providers to accurately and adequately inform risk-benefit considerations for medication use during pregnancy.

 

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

Meeting Date: 8/16/13-8/16/13

Meeting Details:

On August 16, 2013, the Committee will discuss how FDA can communicate more effectively with health care professionals and other stakeholders about the public health risks posed by counterfeit and unapproved drugs, in addition to safe purchasing practices, and how FDA can evaluate that communication and its impact.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsRisk Communication Advisory Committee

Meeting Date: 4/29/13-4/30/13

Meeting Details:

On April 29 and 30, 2013, the Committee will discuss general factors in risk communication about FDA-regulated products, including how to communicate effectively about FDA’s adverse event reporting systems, and messaging in the context of competing communicators.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Reproductive, Drug Safety and Risk AdComm

Meeting Date: 3/5/13-3/5/13

Meeting Details:

The committees will discuss whether the benefit of calcitonin salmon for the treatment of postmenopausal osteoporosis (thinning and weakening of bones that increases the chance of having a broken bone) outweighs a potential risk of cancer. Calcitonin salmon products approved for the treatment of osteoporosis include Miacalcin (calcitonin salmon) injection and nasal spray, submitted by Novartis Pharmaceuticals Corporation; Fortical (calcitonin salmon recombinant) nasal spray, Upsher Smith Laboratories; and the generic equivalents of these products.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsRisk Communication AdComm

Meeting Date: 2/12/13-2/12/13

Meeting Details:

On February 12, 2013, the Committee will discuss general factors in risk communication about FDA regulated products, including approaches to avoid message fatigue and related communication barriers such as prevention or warning fatigue or inaccurate risk perception. 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.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-3:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPostponed: Risk Communication AdComm

Meeting Date: 11/2/12-11/2/12

Meeting Details:

On November 2, 2012, the Committee will discuss general factors in risk communication about FDA regulated products, including approaches to avoid message fatigue and related communication barriers such as prevention or warning fatigue or inaccurate risk perception.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-3:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsRisk Communication AdComm

Meeting Date: 6/29/12-6/29/12

Meeting Details:

On June 29, 2011, the Committee will discuss recent research on communicating and understanding uncertainty, and risk perception and information seeking when facing multiple risks.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-3:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsRisk Communication AdComm

Meeting Date: 5/5/11-5/5/11

Meeting Details:

On May 5, 2011, the Committee will hear and discuss developments in FDA's ongoing communications programs. The discussion will focus on the use of different channels for information dissemination, tracking how information is gathered and spread and thoughts on reaching less accessible target audiences.

 

       
Location: FDA Meeting Room (Rockville) Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsRisk Communication AdComm

Meeting Date: 11/8/10-11/9/10

Meeting Details:

On November 8 and 9, 2010, the Committee will hear and discuss developments in FDA's ongoing communications programs, such as FDA's Strategic Plan for Risk Communication, FDA's Transparency Initiative, and the challenges of effectively communicating with patients and caregivers about appropriate use of medical devices when a patient is prescribed a medical device for home use.

 

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

Meeting Date: 2/25/10-2/26/10

Meeting Details:

On February 25 and 26, 2010, the committee will discuss strategies and lessons from a selection of the FDA's previously issued communications, emphasizing communications challenges. Examples, selected for illustrative purposes only, will be drawn from communications about issues in broad areas such as biologics, drugs, medical devices, regulatory actions, and veterinary products.

 

       
Location: Hilton Hotel Silver Spring, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsRisk Communication AdComm

Meeting Date: 11/12/09-11/13/09

Meeting Details:

On November 12 and 13, 2009, the Committee will discuss strategies and programs designed to communicate with the public about the risks and benefits of FDA-regulated products so as to facilitate optimal use of these products.

 

       
Location: The Hilton Hotel Silver Spring, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsRisk Communication Advisory Committee

Meeting Date: 4/30/09-5/1/09

Meeting Details:

On both days the Committee will discuss the Agency's draft risk communication strategic plan and will be asked for comment and further advice, for example, on strategic priorities for research on effective risk communication.

 

       
Location: tbd Related News Links: Not Available
Time: 8:00AM-5:00PM    
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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    
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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:

tbd

 

       
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    
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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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