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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPharmacy Compounding AdComm

Meeting Date: 5/8/17-5/9/17

Meeting Details:

The committee will receive updates on certain issues to follow up on discussions from previous meetings, including quality standards and conditions at certain compounding facilities. In addition, the committee intends to discuss six bulk drug substances nominated for inclusion on the section 503A Bulks List. FDA will discuss the following nominated bulk drug substances: nicotinamide adenine dinucleotide, nicotinamide adenine dinucleotide disodium reduced, nettle (Urtica dioica) whole plant, ubiquinol, vanadyl sulfate, and artemisinin. The chart below describes which use(s) FDA reviewed for each of the six bulk drug substances being discussed at this advisory committee meeting. The nominators of these substances will be invited to make a short presentation supporting the nomination.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPharmacy Compounding Advisory Committee

Meeting Date: 6/23/16-6/23/16

Meeting Details:

The committee intends to discuss six bulk drug substances nominated for inclusion on the section 503A bulk drug substances list. FDA intends to discuss the following nominated bulk drug substances: chrysin, cesium chloride, sodium dichloroacetate, pyruvic acid, tea tree oil, and 2,3-Dimercapto-1-propanesulfonic acid (DMPS). The nominators of these substances will be invited to make a short presentation supporting the nomination. During the afternoon session, the committee will receive updates on certain issues to follow up on discussions from previous meetings, including the option for obtaining access to investigational new drugs under expanded access.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPharmacy Compounding

Meeting Date: 3/8/16-3/9/16

Meeting Details:

On March 8, 2016, the committee will discuss six bulk drug substances nominated for inclusion on the section 503A bulk drug substances list. FDA will discuss the following nominated bulk drug substances: quinacrine hydrochloride, boswellia, aloe vera 200:1 freeze dried, D-ribose, chondroitin sulfate, and acetyl-L-carnitine. The nominators of these substances will be invited to make a short presentation supporting the nomination. On March 9, 2016, the committee will discuss two categories of drug products nominated for the list of drug products that present demonstrable difficulties for compounding. These categories of drug products are metered dose inhalers and dry powder inhalers. The nominators who nominated the category of drugs or specific drug products in the category will be invited to make a short presentation supporting the nomination.

 

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

Meeting Date: 7/13/00-7/14/00

Meeting Details:

On July 13, 2000, the committee will review five drug products for inclusion on a list of drug products that cannot be compounded because they have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective whereby FDA amended its regulations to include such a list of drug products). In the Federal Register of January 4, 2000 (65 FR 256), FDA published a proposed rule amending these regulations to add two drug products to the list: (1) Aminopyrine (all drug products containing aminopyrine) and (2) astemizole (all drug products containing astemizole). In addition to these two drug products, the committee will review the following three drug products: (1) Grepafloxacin (all drug products containing grepafloxacin), (2) troglitazone (all drug products containing troglitazone), and (3) cisapride (all drug products containing cisapride). Beginning at approximately 10 a.m., and continuing on July 14, 2000, at approximately 8:30 a.m., the committee will discuss and provide FDA with advice about drug products that present demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of those drug products.

 

       
Location: FDA Rockville, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsPharmacy Compounding

Meeting Date: 5/6/99-5/7/99

Meeting Details:

The committee will discuss and provide FDA with advice about the agency's development and publication of a list of bulk drug substances that may be used in pharmacy compounding that do not have a United States Pharmacopeia or National Formulary monograph and are not components of FDA-approved drugs. Specifically, the committee is likely to address the following drug substances as candidates for the bulk drugs list: 4-aminopyridine, 3,4-diaminopyridine, betahistine dihydrochloride, chloramine-T, cyclandelate, dinitrochlorobenzene, diphenylcyclopropenone, hydrazine sulfate, mild silver protein, monosodium asparate, pentylenetetrazole, peruvian balsam, and squaric acid dibutyl ester.

 

       
Location: CDER Advisory Committee Conference Room 1066 56 Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmacy Compounding

Meeting Date: 10/14/98-10/16/98

Meeting Details:

The Committee will address those bulk drug substances that are neither components of FDA approved products nor covered by a USP monograph for inclusion on a list of bulk drug substances that may be used in compounding that qualifies for the applicable statutory exemptions. The Committee will also review drug products to be included on a list which have been withdrawn or removed from the market for reasons of safety or efficacy which may not be used in compounding that qualifies for the applicable statutory exemptions.

 

       
Location: Food and Drug Administration Building Rockville, Related News Links: Not Available
Time: 9:00AM-5:00PM    
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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    
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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    
Materials:
   
       

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Past Meetings

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