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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    
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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    
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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 OptionsNeurological Devices Panel - Sponsor: Sequent Medical, Inc.

Meeting Date: 9/27/18-9/27/18

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Meeting Details:

On September 27, 2018, the Committee will discuss, make recommendations, and vote on the premarket approval application sponsored by Sequent Medical, Inc. for the Woven Endobridge (WEB) Aneurysm Embolization System, which is intended to treat wide-neck intracranial aneurysms arising or located at a vessel bifurcation. The WEB device is being evaluated in the WEB Intrasaccular Therapy Study (WEB-IT): a multicenter, prospective, non-randomized investigation. The Committee will be asked to review the clinical data from the WEB-IT study to help the Agency assess the safety and effectiveness of the device for the proposed indications for use.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm - Sponsor: Genentech & Celltrion

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

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Meeting Details:

The committee will discuss biologics license application 761088 for CT-P10, a proposed biosimilar to Genentech, Inc.'s RITUXAN (rituximab), submitted by Celltrion, Inc. The proposed indications (uses) for this product are for the treatment of adult patients with (1) relapsed or refractory, low-grade or follicular, CD20-positive, B- cell Non-Hodgkin's Lymphoma (NHL) as a single agent; (2) previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to CT-P10 in combination with chemotherapy, as single- agent maintenance therapy; and (3) non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-1:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Analgesic Drug Products AdComm - Sponsor: Trevena Inc.

Meeting Date: 10/11/18-10/11/18

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Meeting Details:

The committee will be asked to discuss new drug application (NDA) 210730, for oliceridine 1 milligram/milliliter injection, submitted by Trevena, Inc., for the management of moderate-to-severe acute pain in adult patients for whom an intravenous opioid is warranted. The committee will also be asked to discuss the efficacy and safety data and benefit-risk considerations.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Analgesic Drug Products AdComm - Sponsor: AcelRX

Meeting Date: 10/12/18-10/12/18

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Meeting Details:

The committee will be asked to discuss new drug application (NDA) 209128, sufentanil sublingual tablets, submitted by AcelRx Pharmaceuticals, Inc., for the management of moderate-to-severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adult patients in a medically supervised setting. The committee will also be asked to discuss risk- benefit considerations and whether this product should be approved.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Gastrointestinal & DSRM AdComm - Sponsor: Sloan Pharma

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

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Meeting Details:

The committees will discuss supplemental new drug application (sNDA) 021200, supplement 015, for ZELNORM (tegaserod maleate) tablets for oral administration, submitted by Sloan Pharma S.[agrave].r.l, Bertrange, Cham Branch, proposed for the treatment of women with irritable bowel syndrome with constipation who do not have a history of cardiovascular ischemic disease, such as myocardial infarction, stroke, transient ischemic attack, or angina, and who do not have more than one risk factor for cardiovascular disease.

 

       
Location: Pooks Hill Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm - Sponsor: Shire

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

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Meeting Details:

The committee will discuss new drug application (NDA) 210166 for prucalopride tablets for oral administration, submitted by Shire Development, LLC, proposed for the treatment of chronic idiopathic constipation in adults.

 

       
Location: Pooks Hill Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 10/24/18-10/25/18

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Meeting Details:

Agenda: On both days, the committee will discuss the ``Guidance for Industry: Diabetes Mellitus--Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes' (https://www.fda.gov/downloads/Drugs/Guidances/ucm071627.pdf), and the cardiovascular risk assessment of drugs and biologics for the treatment of type 2 diabetes mellitus.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology AdComm

Meeting Date: 9/20/18-9/20/18

Meeting Details:

The meeting will focus on two topics related to the Office of Pharmaceutical Quality’s priority of promoting the availability of better medicine. During the morning session, the committee will discuss the modernization of assessing drug applications through a Knowledge-Aided Assessment and Structured Application (KASA) initiative. FDA will seek input on the potential enhancement of a submission format consistent with KASA to improve the efficiency and consistency of regulatory quality assessment. During the afternoon session, the committee will discuss in-vitro/in-vivo relationship standards, and will seek input on establishing patient-focused dissolution standards for oral solid modified-release dosage forms.

 

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

Meeting Date: 9/20/18-9/20/18

Meeting Details:

On Thursday, September 20, 2018, the PAC will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act of 2003 (Pub. L. 108-155). The PAC will meet to discuss the following Center for Drug Evaluation and Research products: INTUNIV LEXAPRO The FDA will provide general safety updates including updates on the following topics without vote by the committee: Overview of FAERS and lack of efficacy; Generic drug approval process; and discussion on trade versus generic drugs; exceptions; Summary of FDA completed review of pediatric safety issues and updated labeling changes for Exjade (deferasirox); Update labeling change for inhaled corticosteroid long-acting ß-2 agonists (ICS/LABAs); Safety labeling for gadolinium.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPharmacy Compounding AdComm

Meeting Date: 9/12/18-9/12/18

Meeting Details:

The committee will receive information on the following two issues to follow up on discussions from previous PCAC meetings: balancing the criteria for the 503A bulk drug substance evaluation and compounding as it relates to dietary supplements. In addition, the committee will discuss six bulk drug substances nominated for inclusion on the 503A Bulks List. FDA will discuss the following nominated bulk drug substances: Alpha lipoic acid, coenzyme Q10, creatine monohydrate, pyridoxal 5 phosphate, choline chloride, and quercetin. The chart below identifies the 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. Drug - > Uses Reviewed - >(alpha lipoic acid) Diabetic neuropathy and associated pain, acute liver toxicity from Amanitaspp. mushroom poisoning and other toxins, hepatitis C, cancer, cirrhosis, fibromyalgia, and muscle pain (coenzyme Q10) Mitochondrial disorders (creatine monohydrate) Mitochondrial disorders (pyridoxal 5 phosphate) Epilepsy and seizure disorders (choline chloride) Hepatic steatosis, supplementation in long term total parenteral nutrition, non-alcoholic fatty liver disease, fetal alcohol spectrum disorder, and atherosclerosis (quercetin dihydrate) Asthma, allergy, cancer prevention and treatment, and hypertension

 

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

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Past Meetings

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