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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    
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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    
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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 OptionsAnesthetic and Analgesic Drug Products AdComm

Meeting Date: 11/24/14-11/25/14

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Meeting Details:

The committee will discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management. The committee will also consider the efficacy of ESI and the overall risk benefit balance of injecting steroids in the epidural space to treat pain. These considerations will assist the Agency in our discussions of possible regulatory options, including but not limited to changes to the product labeling.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drug AdComm

Meeting Date: 12/4/14-12/4/14

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Meeting Details:

The committee will discuss issues related to clinical development programs and clinical trial designs for antibacterial products for the treatment of patients with serious bacterial infections for which there are limited or no therapeutic options.

 

       
Location: The Marriott Inn and Conference Center Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs AdComm - Cerexa Inc.

Meeting Date: 12/5/14-12/5/14

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Meeting Details:

The committee will discuss new drug application (NDA) 206494 for ceftazidime-avibactam for injection, submitted by Cerexa Inc., for the proposed indications of: Complicated Intra-abdominal Infections, Complicated Urinary Tract Infections, including Acute Pyelonephritis and Limited Use Indication: Aerobic Gram-negative Infections with Limited Treatment Options.

 

       
Location: Univ. of Maryland Related News Links: Not Available
Time: 8:00AM-4:30AM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee

Meeting Date: 12/11/14-12/11/14

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Meeting Details:

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) GANETESPIB, application submitted by Synta Pharmaceuticals Corp. (2) Etirinotecan, application submitted by Nektar Therapeutics, and (3) RO5503781, application submitted by Hoffmann-La Roche, Inc.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 12/12/14-12/12/14

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Meeting Details:

On December 12, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Superion InterSpinous Spacer device sponsored by Vertiflex Incorporated. The proposed Indication for Use for the Superion InterSpinous Spacer device, as stated in the PMA, is as follows: the Superion InterSpinous Spacer (the Superion ISS) is intended to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate lumbar spinal stenosis, with or without Grade 1 spondylolisthesis, confirmed by X-ray, MRI and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. The Superion ISS is indicated for those patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, numbness, and/or cramping, with or without back pain. The Superion ISS may be implanted at one or two adjacent lumbar (L) levels in patients in whom treatment is indicated at no more than two levels, from L1 to L5.

 

       
Location: Holiday Inn-College Park Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsDrug Safety and Risk Management

Meeting Date: 11/18/14-11/18/14

Meeting Details:

The committee will discuss the Food and Drug Administration Amendments Act of 2007 which requires FDA to bring, at least annually, one or more drugs with Risk Evaluation and Mitigation Strategies (REMS) with elements to assure safe use (ETASU) before the Drug Safety and Risk Management (DSaRM) Advisory Committee. The Agency plans to discuss the risk management of eculizumab (SOLIRIS). The Agency will seek public input whether the REMS with ETASU for this drug assures safe use of the drug, is not unduly burdensome on patient access to the drug, and to the extent practicable, minimizes the burden on the health care delivery system.

 

       
Location: The Great Room Related News Links: Not Available
Time: 9:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 11/14/14-11/14/14

Meeting Details:

On November 14, 2014, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the AcrySof® IQ ReSTOR® Multifocal Toric Posterior Chamber Intraocular Lens submitted by applicant Alcon Laboratories, Inc. This intraocular lens combines the optical properties of a +3 diopter multifocal intraocular lens with the optical properties of a toric intraocular lens. The proposed indication for use is: The AcrySof® IQ ReSTOR® Multifocal Toric Posterior Chamber Intraocular Lens (IOL) are intended for primary implantation for the visual correction of aphakia and pre-existing astigmatism secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual refractive cylinder, and increased spectacle independence. The lens is intended to be placed in the capsular bag.

 

       
Location: Hilton/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 11/6/14-11/6/14

Meeting Details:

During the morning session, the committee will discuss New Drug Application (NDA) 205353, panobinostat capsules, application submitted by Novartis Pharmaceuticals Corporation. The proposed indication (use) for this product is in combination with bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least 1 prior therapy. During the afternoon session, the committee will discuss NDA 206317, ferric pyrophosphate solution, for administration via hemodialysis dialysate, application submitted by Rockwell Medical, Inc. The proposed indications (uses) for this product are for the treatment of iron loss or iron deficiency to maintain hemoglobin in adult patients with hemodialysis-dependent stage 5 chronic kidney disease (CKD 5HD) and to reduce the prescribed dose of erythropoiesis stimulating agent (ESA) required to maintain desired hemoglobin levels.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 10/30/14-10/30/14

Meeting Details:

The committee will discuss new drug application (NDA) 206316, edoxaban tablets, submitted by Daiichi Sankyo, Inc., for the prevention of stroke and systemic embolism (blood clots other than in the head) in patients with nonvalvular atrial fibrillation (A Fib; abnormally rapid and chaotic contractions of the atria, the upper chambers of the heart).

 

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

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Past Meetings

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