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Past Meetings

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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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 OptionsVaccines and Related Biological Products AdComm

Meeting Date: 9/13/17-9/13/17

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Meeting Details:

On September 13, 2017, the Vaccines and Related Biological Products Committee (VRBPAC) will meet in an open session to discuss and make recommendations on the safety and effectiveness of Zoster Vaccine Recombinant (Adjuvanted) [Shingrix], manufactured by GlaxoSmithKline Biologicals.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 9/19/17-9/19/17

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Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 021938/033 SUTENT (sunitinib malate) oral capsules, submitted by C.P. Pharmaceuticals International C.V., represented by Pfizer, Inc. (authorized U.S. agent). The proposed indication (use) for this product is for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy.

 

       
Location: tbd Related News Links: Not Available
Time: 8:30AM-1:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsArthritis AdComm

Meeting Date: 8/2/17-8/3/17

Meeting Details:

DAY 1 - 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. - DAY 2 - The committee will discuss supplemental new drug applications (sNDAs) 203214 supplement 17, for XELJANZ (tofacitinib) tablets and 208246 supplement 3, for XELJANZ XR (tofacitinib) extended release tablets submitted by Pfizer Inc., for the treatment of adult patients with active psoriatic arthritis. The committee will discuss the efficacy and safety data and benefit-risk considerations.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

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

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: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Analgesic with DSRM AdComm

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

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    
Materials:
   
       

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Past Meetings

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