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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsDrug Abuse Advisory Committee

Meeting Date: 4/20/99-4/20/99

Meeting Details:

The committee will be discussing appropriate patient populations and outcome measures for clinical trials for drugs to treat alcohol use disorders. On April 20, 1999, from 1:30 p.m. to 4 p.m., the committee will hear trade secret and/or confidential information relevant to pending investigational new drugs (INDs). This portion of the meeting will be closed to permit discussion of this information.

 

       
Location: CDER/Advisory Committee Conference Room 5630 Fish Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDrug Abuse Advisory Committee

Meeting Date: 4/27/98-4/28/98

Meeting Details:

The scientific evidence for initiating a scheduling action for ULTRAM(R) (tramadol hydrochloride), R.W. Johnson Pharmaceutical Research Institute, under the Controlled Substance Act.

 

       
Location: Holiday Inn, Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsDrug Abuse

Meeting Date: 6/9/97-6/10/97

Meeting Details:

The committee discussed the labeling of smoking cessation products.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsDrug Abuse Advisory Committee

Meeting Date: 2/10/97-2/11/97

Meeting Details:

On February 10, 1997, the committee will discuss Quit TM Brand silver acetate lozenges, New Life Health Products, for smoking cessation. On February 11, 1997, the committee will discuss new drug application (NDA) 11-792, Soma (carisoprodol generic tablets, Wallace Laboratory), for muscle relaxation and generic drugs containing carisoprodol. The committee will consider a Drug Enforcement Administration petition regarding scheduling of carisoprodol under the Controlled Substances Act.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsDrug Abuse Advisory Committee

Meeting Date: 12/12/96-12/13/96

Meeting Details:

Wellbutrin SR for smoking cessation Nicotrol nicotine inhaler for smoking cessation

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsDrug Abuse Advisory Committee

Meeting Date: 9/29/95-9/29/95

Meeting Details:

The Nonprescription Drugs Advisory Committee reviews and evaluates data concerning the safety and effectiveness of over-the-counter (nonprescription) human drug products for use in the treatment of a broad spectrum of human symptoms and diseases. The Endocrinologic and Metabolic Drugs Advisory Committee reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in endocrine and metabolic disorders. The Drug Abuse Advisory Committee advises on the scientific and medical evaluation of information gathered by the Department of Health and Human Services and the Department of Justice on the safety, efficacy, and abuse potential of drugs and recommends actions to be taken on the marketing, investigation, and control of such drugs. The Gastrointestinal Drugs Advisory Committee reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in gastrointestinal diseases.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint OTC & Drug Abuse

Meeting Date: 9/28/95-9/28/95

Meeting Details:

Nonprescription Drugs Advisory Committee and the Drug Abuse Advisory Committee will discuss data relevant to NDA 20-066 (Nicorette 4 milligrams (mg) and NDA 18-612 (Nicorette 2 mg) to switch nicotine polacrilex (Nicorette, SmithKline Beecham Consumer Healthcare Products) from prescription to over-the-counter status for use as an aid to smoking cessation for the relief of nicotine withdrawal symptoms.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsDrug Abuse

Meeting Date: 4/7/95-4/7/95

Meeting Details:

On April 7, 1995, the committee will discuss the 1995 Institute of Medicine Report on the Development of Medications for the Treatment of Opiate and Cocaine Addiction.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsDrug Abuse

Meeting Date: 8/1/94-8/3/94

Meeting Details:

N/A

 

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

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm

Meeting Date: 6/26/18-6/26/18

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Meeting Details:

The committees will discuss new drug application 022324, oxycodone extended-release capsules, submitted by Pain Therapeutics, with the proposed indication of the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is intended to have abuse-deterrent properties based on its physicochemical properties. The committees will be asked to discuss whether the data submitted by the Applicant are sufficient to support labeling of the product with the properties expected to deter abuse. Closed Committee Deliberations: On June 26, 2018, from 8 a.m. to 9:30 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)). During this session, the committees will discuss the drug development program of an investigational opioid formulation with properties designed to deter abuse.

 

       
Location: DoubleTree, Bethesda, MD Related News Links: Not Available
Time: 9:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 7/25/18-7/25/18

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Meeting Details:

The committee will discuss supplemental biologics license application (sBLA) 125526 for mepolizumab for injection, submitted by GlaxoSmithKline for add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD) guided by blood eosinophil counts.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee of the ODAC

Meeting Date: 6/20/18-6/20/18

Meeting Details:

The particular matter for this meeting will be review and discussion of a list of molecular targets for which evidence and/or biologic rationale exist to determine their potential relevance to the growth or progression of one or more pediatric cancers and a list of those targets deemed unlikely to be associated with the growth or progression of pediatric tumors. These lists are expected to fulfill the statutory obligation of the Food and Drug Administration Reauthorization Act (FDARA) and provide some guidance to industry in planning for initial Pediatric Study Plan submissions for new drug and/or biologic products in development for cancer in accordance with the amended provisions of the Pediatric Research Equity Act. The committee will review and discuss considerations other than scientific relevance that FDA will include in decision making with respect to the need and timing of pediatric evaluation of specific new drug and biologic products. The committee will discuss possible criteria and mechanisms for the prioritization by sponsors and the clinical investigator community of select targeted new agents for pediatric evaluation especially in the setting of multiple same in class agents. Preliminary discussion will focus on approaches to coordination and collaboration for pediatric clinical investigations of new agents that might be pursued to efficiently accommodate international regulatory requirements and global pediatric product development. The open public hearing sessions are: Topic 1: Target List, Topic 2: FDARA Implementation, and Topic 3: Mechanisms to Assure Efficiency and to Enhance Global Coordination Through International Collaboration.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAnesthesiology and Respiratory Therapy Devices Panel of the MDAC

Meeting Date: 6/14/18-6/14/18

Meeting Details:

The committee will discuss, make recommendations and vote on information related to PneumRx, Inc.’s premarket approval application for the PNEUMRX ELEVAIR Endobronchial Coil System, which is a first of a kind implantable lung reduction coil for the proposed indication for use in patients with homogeneous and/or heterogeneous severe emphysema to improve quality of life, lung function, and exercise capacity.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the MDAC

Meeting Date: 6/12/18-6/12/18

Meeting Details:

On June 12, 2018, the committee will discuss, make recommendations, and vote on the premarket approval application sponsored by Cordis, Inc. for the INCRAFT AAA Stent Graft System, which is intended for the endovascular treatment of infra-renal abdominal aortic aneurysms in patients with appropriate anatomy. The INCRAFT device is being evaluated in the INSPIRATION study, a multicenter, prospective, non-randomized investigation. The study met its primary safety and effectiveness endpoints, but results also showed higher than anticipated rates of certain adverse events. The committee discussion will focus on how these events impact the long-term safety and effectiveness, as well as the benefit/risk profile of the device.

 

       
Location: Hilton Gburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic & Analgesic with DSRM AdComm

Meeting Date: 5/22/18-5/22/18

Meeting Details:

The committees will be asked to discuss new drug application (NDA) 209588, for buprenorphine sublingual spray, submitted by INSYS Development Company, Inc., for the treatment of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate. The committees will also be asked to discuss whether this product should be approved.

 

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

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Past Meetings

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