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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 OptionsJoint Meeting of the Psychopharmacologic Drugs AdComm and the DSRM AdComm

Meeting Date: 10/31/17-10/31/17

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Meeting Details:

The committees will discuss new drug application (NDA) 209819, buprenorphine subcutaneous injection, submitted by Indivior Pharmaceuticals, Inc., for treatment of opioid dependence.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Psychopharmacologic Drugs AdComm and the DSRM AdComm

Meeting Date: 11/1/17-11/1/17

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Meeting Details:

The committees will discuss new drug application (NDA) 210136, buprenorphine subcutaneous injection, submitted by Braeburn Pharmaceuticals, Inc., for treatment of opioid dependence.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

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

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Meeting Details:

On November 7, 2017, the Vaccines and Related Biological Products Committee (VRBPAC) will meet in an open session to discuss and make recommendations on the clinical development plan for Pfizer’s investigational Staphylococcus aureus vaccine intended for pre-surgical prophylaxis in elective orthopedic surgical populations.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs Advisory Committee

Meeting Date: 11/16/17-11/16/17

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Meeting Details:

The committee will discuss new drug application (NDA) 209367, ciprofloxacin inhalation powder, sponsored by Bayer HealthCare Pharmaceuticals, Inc., for the proposed indication of reduction of exacerbations in non-cystic fibrosis bronchiectasis (NCFB) adult patients (=18 years of age) with respiratory bacterial pathogens.

 

       
Location: tbd Related News Links: Not Available
Time: 8:30AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsBone, Reproductive and Urologic Drugs AdComm

Meeting Date: 12/7/17-12/7/17

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Meeting Details:

The committee will discuss appropriate patient selection criteria and clinical trial design features, including acceptable endpoints, for demonstrating clinical benefit for drugs intended to treat interstitial cystitis and bladder pain syndrome. The committee will also discuss whether bladder pain syndrome and interstitial cystitis reflect overlapping or different populations, and whether it is appropriate to assess efficacy in the same way for both conditions.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 12/12/17-12/12/17

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Meeting Details:

On December 12, 2017, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the Barricaid Anular Closure Device by Intrinsic Therapeutics. The proposed Indication for Use, as stated in the PMA, is as follows: The Barricaid is intended to be implanted following a limited discectomy, to prevent reherniation and the recurrence of pain or dysfunction. The Barricaid is indicated for patients with radiculopathy (with or without back pain), a posterior or posterolateral herniation, characterized by radiographic confirmation of neural compression using magnetic resonance imaging, and a large anular defect (e.g., between 4-6 mm tall and between 6-12 mm wide) post discectomy, at one level between L4 and S1.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs Advisory Committee

Meeting Date: 10/18/17-10/18/17

Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 209637 for semaglutide injection, submitted by Novo Nordisk, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

 

       
Location: Tommy Douglas Conference Center Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic & Ophthalmic Drugs AdComm

Meeting Date: 10/13/17-10/13/17

Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 208254, for netarsudil ophthalmic solution 0.02%, submitted by Aerie Pharmaceuticals Inc., for the proposed indication to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

 

       
Location: FDA Meeting Related News Links: Not Available
Time: 8:30AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue and Gene Therapies AdComm

Meeting Date: 10/12/17-10/12/17

Meeting Details:

On October 12, 2017, the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) will meet in an open session to discuss and make recommendations on the safety and effectiveness of Biologics License Application (BLA) 125610, voretigene neparvovec, submitted by Spark Therapeutics, Inc. The proposed indication (use) for this product is treatment of patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 10/4/17-10/4/17

Meeting Details:

On October 4, 2017, the Vaccines and Related Biological Products Committee (VRBPAC) will meet in an open session to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2018 southern influenza season.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 1:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPCNS AdComm

Meeting Date: 9/28/17-9/28/17

Meeting Details:

The committee will discuss new drug application (NDA) 200896, ataluren for oral suspension, sponsored by PTC Therapeutics, Inc., for the treatment of patients with dystrophinopathy due to a nonsense mutation in the dystrophin gene.

 

       
Location: FDA Meeting Room (TD) Related News Links: Not Available
Time: 9:00AM-4:30PM    
Materials:
   
       

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Past Meetings

Below is a listing of all committees. Select a committee to display all meetings available for that committee.

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