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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    
Materials:
   
       

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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    
Materials:
   
       

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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 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    
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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    
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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    
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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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