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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs AdComm

Meeting Date: 9/3/14-9/5/14

Meeting Details:

The committee will discuss the standards used to demonstrate that over-the-counter (OTC) topical antiseptics used in healthcare settings are generally recognized as safe and effective. The discussion will focus on antiseptic active ingredients marketed under the OTC Drug Review (also known as the OTC Drug Monograph) for the following healthcare antiseptic uses: healthcare personnel hand washes and rubs, surgical hand scrubs and rubs, and patient preoperative and preinjection skin preparations. On September 4-5, 2014, the committee will discuss the scope of safety testing that should be required for sunscreen active ingredients to be marketed in U.S. over-the-counter (OTC) sunscreen products. This discussion will take into consideration that sunscreens are typically used chronically in individuals over the age of 6 months to help prevent skin cancer and skin aging. The need for various types of safety data, including clinical data and nonclinical data, will be discussed.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs AdComm

Meeting Date: 5/2/14-5/2/14

Meeting Details:

The committee will discuss data submitted by MSD Consumer Care, Inc., to support a new drug application (NDA) 204804 for over-the-counter (OTC) marketing of montelukast 10 milligram (mg) tablets (proposed trade name SINGULAIR Allergy). The proposed OTC use is "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: Nasal congestion, runny nose, itchy, watery eyes, sneezing, itching of the nose.” The applicant proposes to label the product for OTC use in adults 18 years and older. Efficacy and safety data, as well as results of consumer studies, will be discussed. The committee will be asked to consider whether the data support an acceptable risk/benefit profile for the nonprescription use of montelukast tablets by OTC consumers.

 

       
Location: Hilton Gaithersburg Related News Links: Not Available
Time: 8:00AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs AdComm

Meeting Date: 7/31/13-7/31/13

Meeting Details:

The committee will discuss data submitted by sanofi-aventis U.S., LLC to support a supplemental new drug application (sNDA) 20468/S-035, for the switch from prescription to over-the-counter (OTC) of triamcinolone acetonide nasal spray. The proposed OTC use is "temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion, runny nose, sneezing, itchy nose." The applicant proposes to label the product for OTC use in adults and children. The data to be discussed will include studies addressing the potential adverse effects, as well as a summary of the postmarketing experience with the triamcinolone acetonide nasal spray addressing the potential for both systemic and local effects. The committee will be asked to consider whether the data support the appropriate and safe use of triamcinolone acetonide nasal spray by OTC consumers.

 

       
Location: FDA Meeting Room Silver Spring MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs AdComm

Meeting Date: 11/9/12-11/9/12

Meeting Details:

On November 9, 2012, the committee will discuss data submitted by MSD Consumer Care, Inc. to support new drug application (NDA) 202211, for the partial switch from prescription to over-the-counter (OTC) of the oxybutynin transdermal system (proposed trade name OXYTROL FOR WOMEN). The proposed OTC use is "treats overactive bladder in women." The data to be discussed will include a summary of the postmarketing experience with the oxybutynin transdermal system, and the results of consumer studies, including label comprehension studies, self-selection studies, and an actual use study. The committee will be asked to consider whether the data support the appropriate and safe use of oxybutynin transdermal system by OTC consumers.

 

       
Location: DoubleTree by Hilton Hotel Washington DC/Silver Spring Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsUsing Innovative Technologies: Nonprescription Drugs

Meeting Date: 3/22/12-3/23/12

Meeting Details:

The U.S. Food and Drug Administration (FDA or the Agency) is announcing a public hearing to obtain input on a new paradigm we are considering. Under this paradigm, the Agency would approve certain drugs that would otherwise require a prescription for nonprescription use (also known as over-the-counter or OTC) under conditions of safe use. These conditions of safe use would be specific to the drug product and might require sale in certain pre-defined health care settings, such as a pharmacy. This public hearing is being held to obtain information and comments from the public on the feasibility of this paradigm and its potential benefits and costs.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 9:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription and Pediatric Drugs AdComm

Meeting Date: 5/17/11-5/18/11

Meeting Details:

On May 17 and 18, 2011, the committees will review pertinent pharmacokinetic (how drugs are absorbed, distributed, used, and eliminated by the body), safety and efficacy data, and discuss whether new dosing information for oral over-the-counter (OTC) drug products containing acetaminophen should be added to the label for children less than 2 years of age. In addition, the committees will consider adding a weight-based dosing regimen to the existing age-based dosing regimen for children 2 to 12 years of age. Dosing for children 12 years of age and older will not be discussed. Lastly, the committees will discuss ways that administration by caregivers can be improved so that medication errors can be minimized.

 

       
Location: Hilton Silver Spring, Maryland Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs AdComm

Meeting Date: 12/14/07-12/14/07

Meeting Details:

The committee will discuss the safety and effectiveness of phenylephrine hydrochloride and phenylephrine bitartrate as over-the-counter (OTC) oral nasal decongestants. The discussion at the meeting will address a citizen petition submitted to FDA on February 1, 2007 (Docket No. 2007P-0047/CP1), which asserts that the available data do not support the adult and pediatric doses of phenylephrine hydrochloride and phenylephrine bitartrate that are generally recognized as safe and effective in the OTC drug monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products (CCABADP) in 21 CFR part 341. The meeting will focus on the review of existing safety and efficacy data and the petitioner's request that the CCABADP monograph be amended to increase the adult dose of phenylephrine hydrochloride from 10 to 25 milligrams (mg) and that of phenylephrine bitartrate from 15.6 to 40 mg.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint NDAC and ENDAC Meeting

Meeting Date: 12/13/07-12/13/07

Meeting Details:

The committees will evaluate data submitted by Merck & Co., Inc., to support the over-the-counter use of MEVACOR (lovastatin) 20 milligrams (mg) a day to help lower cholesterol which may prevent a first heart attack.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee

Meeting Date: 10/18/07-10/19/07

Meeting Details:

The committees will meet in joint session to discuss the safety and efficacy of over-the-counter (OTC) cough and cold products marketed for pediatric use. A citizen petition was submitted to FDA on March 1, 2007, that raised concerns about the safety and efficacy of cough and cold products in children under 6 years of age. The petition requested among other things that FDA amend the OTC drug monograph for Cold, Cough, Allergy, Bronchodilator, and ntiasthmatic Drug Products (CCABADP) in 21 CFR Part 341 to require that labeling for OTC antitussive, expectorant, nasal decongestant, antihistamine, and combination cough and cold products state that these products have not been found to be safe or effective in children under 6 years of age for the treatment of cough and cold, and that these products should not be used for the treatment of cough and cold in children under 6 years of age. In addition, the petitioner requested the agency to notify manufacturers of these products whose labeling either uses such terms as ``infant'' or ``baby'' or displays images of children under the age of 6, that such marketing is not supported by scientific evidence and that manufacturers will be subject to enforcement action at any time.

 

       
Location: tbd Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs AdComm

Meeting Date: 9/25/06-9/25/06

Meeting Details:

The committee will consider issues related to the analysis and interpretation of consumer behavior studies conducted to support marketing of nonprescription drug products.

 

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

Meeting Date: 1/24/06-1/24/06

Meeting Details:

The committee will discuss the continued need for the designation of OTC epinephrine-metered dose inhalers for the treatment of asthma as an essential use of ozone-depleting substances (ODSs) under § 2.125 (21 CFR 2.125). ODSs are substances that deplete the stratospheric ozone, which include chlorofluorocarbons (CFCs). Once released, CFCs rise to the stratosphere. In the stratosphere, CFCs are gradually broken down by strong ultraviolet light, and they release chlorine atoms that then deplete stratospheric ozone. Depletion of stratospheric ozone by CFCs and other ODSs leads to higher ultraviolet B radiation levels, which in turn increase skin cancers and cataracts, as well as cause other significant environmental damage. FDA is soliciting comments and data to support or refute an essential-use designation for OTC epinephrine metered-dose inhaler (MDI) drug products. These products include the only OTC drug available in an MDI dosage form for the treatment of asthma. The OTC epinephrine MDIs use CFCs as propellants. The OTC indication is ‘‘for temporary relief of shortness of breath, tightness of chest, and wheezing due to bronchial asthma.’’ In some instances, use of this product early during an asthma attack could avert a serious or life-threatening worsening of the attack. There are currently a limited number of marketed OTC drug products containing epinephrine in a MDI dosage form. According to § 2.125(f)(1), the following are criteria for continued ODS essential-use designation: (1) Substantial technical barriers exist to formulating the product without ODSs; (2) The product will provide an otherwise unavailable important public health benefit; and (3) Use of the product does not release cumulative significant amounts of ODSs into the atmosphere or the release is warranted in view of the high probability of an unavailable important public health benefit. Under section 610 of the Clean Air Act (42 U.S.C. 7671(i)), MDIs that are not the subject of an essential-use designation cannot be legally distributed in interstate commerce. We particularly encourage comments on the second criterion in § 2.125(f)(i) regarding the public health benefit derived from the availability of these products in the OTC setting. Information that may aid in the Committee’s discussion of essential use includes: • Who currently uses OTC epinephrine MDIs? • How many of these MDIs are used annually? • What are the alternatives if these products are no longer available? • From literature sources, what is the value of use of the product to the users, and why do they use it? • What established treatment guidelines recommend the use of OTC epinephrine? • How many people with asthma do not have ready access to prescription medication through healthcare professionals?

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription & Endocrinologic and Metabolic Drugs AdComm

Meeting Date: 1/23/06-1/23/06

Meeting Details:

The committees will consider the safety and efficacy of new drug application (NDA) 21-887, proposing over-the-counter (OTC) use of ORLISTAT (tetrahydrolipstatin) capsules (60 milligrams (mg)), GlaxoSmithKline Consumer Healthcare, L.P., to promote weight loss in overweight adults when used along with a reduced calorie and low fat diet.

 

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

Meeting Date: 10/20/05-10/20/05

Meeting Details:

The committee will discuss the benefits and risks of antiseptic products marketed for consumer use (e.g., antibacterial hand-washes and bodywashes). The discussion will include topics such as the efficacy of antiseptics intended for use by consumers and potential risks to the individual and the general population from using these products.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs Advisory Committee

Meeting Date: 3/23/05-3/23/05

Meeting Details:

The committee will discuss the microbiologic surrogate endpoints used to demonstrate the effectiveness of antiseptic products used in health care settings. The discussion will also focus on related public health issues, trial design, and statistical issues.

 

       
Location: Hilton Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the OTC Drugs AdComm and the Endocrinologic and Metabolic Drugs AdComm

Meeting Date: 1/13/05-1/14/05

Meeting Details:

On both days, the committees will consider the safety and efficacy of new drug application (NDA) 21-213, proposing over-the-counter (OTC) use of MEVACOR (lovastatin), 20 milligrams a day, Merck & Co., Inc., to help lower LDL "bad" cholesterol, which may prevent a first heart attack.

 

       
Location: Holiday Inn Versailles Ballrooms 8120 Wisconsin Avenue Bethesda, MD 20814 Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Nonprescription and the Dermatologic and Ophthalmic Drugs Advisory Committee

Meeting Date: 5/6/04-5/7/04

Meeting Details:

On both days, the committee will discuss efficacy and labeling issues for over-the-counter drug products used in the treatment of tinea pedis (interdigital) in patients 12 years of age and over.

 

       
Location: Rockville, MD Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs Advisory Committee

Meeting Date: 6/12/03-6/12/03

Meeting Details:

The committee will consider the safety and efficacy of ipecac syrup, indicated for emergency use to cause vomiting in poisoning, for continued over-the-counter (OTC) status under 21 CFR 201.308. The primary areas of consideration are: (1) the status of the role of ipecac syrup in gastrointestinal decontamination; (2) whether the literature clearly defines the risk/benefit ratio of ipecac syrup; (3) the role of ipecac syrup in poison treatment for populations with limited access to emergency medical treatment; (4) if there is significant abuse of ipecac syrup; and (5) alternative therapies to ipecac syrup.

 

       
Location: HOL - Beth Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs Advisory Committee

Meeting Date: 9/19/02-9/20/02

Meeting Details:

On September 19, 2002, the committee will discuss safety issues related to the use of acetaminophen. The primary area for discussion will focus on potential hepatotoxicity related to the use of acetaminophen in both over-the-counter (OTC) and prescription (RX) products. On September 20, 2002, the committee will discuss safety issues related to the use of aspirin and other OTC nonsteroidal anti-inflammatory drugs (NSAIDS). The primary areas for discussion will focus on potential gastrointestinal bleeding and renal insufficiency related to the use of these products. In rulemaking, the agency has proposed aspirin and acetaminophen as category I ingredients for safety and effectiveness. Other NSAIDS and combination products are marketed under new drug applications. The agency continues to believe that these ingredients are safe and effective in the prescription and OTC products currently on the market when properly used. The advisory committee will discuss whether labeling or other measures are warranted to reduce the risk of occurrence or the severity of these adverse reactions.

 

       
Location: Silver Spring, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription & GI Drugs AdComm

Meeting Date: 6/21/02-6/21/02

Meeting Details:

The committees will consider the safety and efficacy of new drug application (NDA) 21-229, proposing over-the-counter (OTC) use of PRILOSEC1 (omeprazole magnesium), AstraZeneca LP/Procter and Gamble, for the prevention of the symptoms of frequent heartburn. The sponsor proposes a 20 milligram dose to be taken for 14 days.

 

       
Location: HOL - Bethesda Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs Advisory Committee

Meeting Date: 4/22/02-4/22/02

Meeting Details:

On April 22, 2002, the committee will consider the safety and efficacy of new drug applications (NDA): NDA 19-658, CLARITIN Tablet; NDA 20-704, CLARITIN RediTab; and NDA 20-641, CLARITIN Syrup. These three CLARITIN products (loratadine, Schering-Plough Corp.) are immediate release formulations of the products that are proposed for over-the-counter (OTC) use for the relief of symptoms associated with allergic rhinitis and chronic idiopathic urticaria (CIU). The primary purpose of the meeting is to discuss CIU as an OTC indication.

 

       
Location: Holiday Inn in Bethesda, Md. Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs Advisory Committee

Meeting Date: 5/11/01-5/11/01

Meeting Details:

The committees will consider Citizen Petition 98P-0610/CP1, submitted by Blue Cross of California, that requested the agency to convert Allegra (fexofenadine hydrochloride), Claritin (loratadine) and Zyrtec (cetrizine hydrocholoride) to over-the-counter status.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs Advisory Committee

Meeting Date: 10/19/00-10/19/00

Meeting Details:

The committee will consider safety issues regarding the use of Phenylpropanolamine (PPA) in over-the-counter (OTC) drug products. The discussion will focus on the reported results of an epidemiological study designed to assess the risk of hemorrhagic stroke associated with the use of PPA. The Consumer Health Products Association (CHPA) commissioned the study which was conducted by Yale University.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Endocrinologic & Metabolic and Nonpresciption Advisory Committee

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

Meeting Details:

At a July 13-14, 2000 joint meeting, FDA's Nonprescription and Endocrine & Metabolic Drugs Advisory Committees will review Rx-to-OTC switch applications for Bristol-Myers Squibb's Pravachol (pravastatin) and Merck's Mevacor (lovastatin) for lowering cholesterol.

 

       
Location: Holiday Inn, Bethesda, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs

Meeting Date: 7/12/00-7/12/00

Meeting Details:

The committee will discuss the remarketing and labeling of the Today Vaginal Contraceptive Sponge, new drug application (NDA) 18-683, Allendale Pharmaceuticals. This product was approved by FDA in 1983, but has not been marketed since January 1995.

 

       
Location: Holiday Inn Bethesda, MD. Related News Links: Not Available
Time: 1:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs

Meeting Date: 9/11/98-9/11/98

Meeting Details:

Discussion of draft guidance for the over-the-counter (OTC) vaginal antifungal class labeling.

 

       
Location: Holiday Inn Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs

Meeting Date: 7/28/98-7/29/98

Meeting Details:

On July 28, 1998, the Nonprescription Drugs Advisory Committee will discuss class labeling for over-the-counter (OTC) vaginal antifungal drug products. In the FEDERAL REGISTER of February 27, 1997 (62 FR 9024), the agency published a proposed rule intended to enable consumers to better read and understand OTC drug product labeling and to better apply this information in the labeling to the safe and effective use of such products. An important element of FDA’s proposed rule is a standardized labeling format for OTC drug products. The agency has developed class labeling for OTC vaginal antifungal drug products in accordance with the February 27, 1997, proposed rule. The committee will discuss the agency’s draft guidance document for industry entitled "Class Labeling of OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis)" and other related issues. The draft guidance document is intended to provide guidance for both the carton and educational brochure. In the next several weeks after publication of this notice, a copy of the draft guidance document for industry will be on display in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20857 between 9 a.m. and 4 p.m. Monday through Friday. On July 29, 1998, the Nonprescription Drugs Advisory Committee will meet to discuss effectiveness testing for final formulations of health-care antiseptic drug products relative to performance expectations for these OTC drug products. In the FEDERAL REGISTER of June 17, 1994 (59 FR 31402 through 31452) the agency published a proposed rule for OTC health-care antiseptic drug products, i.e., patient preoperative skin preparations, surgical hand scrubs, and health-care personnel and antiseptic handwashes. Included in the proposed rule are key characteristics for each drug product class of health-care antiseptic drug products (i.e., definitions), a requirement for final formulation testing, effectiveness standards, and labeling of each of the drug product categories. In response to the proposed rule, the agency received comments to consider six drug product categories (preoperative skin preparation, surgical hand scrub, health-care personnel handwash, food handler handwash, antimicrobial handwash, and antimicrobial bodywash). Comments also proposed alternate: (1) Testing requirements, (2) key characteristics, and (3) labeling for each of the categories. FDA is seeking the recommendations of the Committee and experts on appropriate performance expectations for OTC health-care antiseptic drug products and how these final formulations should be tested.

 

       
Location: Holiday Inn, Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsDental Plaque Subcommittee Meeting of the Nonprescription Drugs Advisory Committee

Meeting Date: 10/29/97-10/30/97

Meeting Details:

On October 29, 1997, the subcommittee will continue discussion and/or possibly vote on the safety and effectiveness of: C- 31G, xylitol, and zinc citrate, as well as the following combination ingredients: (1) Menthol, thymol, eucalyptol, and methyl salicylate; (2) hydrogen peroxide and povidone iodine; and (3) hydrogen peroxide, sodium citrate, zinc chloride, and sodium lauryl sulfate. The subcommittee will also continue discussion of the criteria for over- the-counter (OTC) antiplaque and antigingivitis combination drug products. On October 30, 1997, the subcommittee will discuss the final formulation testing for OTC antiplaque and antigingivitis drug products, and assignments will be made for the review of foreign marketing data supporting OTC antiplaque and antigingivitis ingredients.

 

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

Meeting Date: 9/18/97-9/18/97

Meeting Details:

The Committee will discuss issues relating to the labeling and dosing of over-the-counter (OTC) pediatric analgesic/antipyretic drug products. The Committee will discuss topics such as: (1) What is an appropriate lower age limit for the dosing of OTC analgesic/ antipyretic drug products; and (2) the safety implications of the OTC availability of children's analgesic/antipyretic suspension products and double concentrated infant drops with overlapping age directions.

 

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

Meeting Date: 7/14/97-7/14/97

Meeting Details:

FDA standardized labeling OTC drug products.

 

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

Meeting Date: 4/15/97-4/15/97

Meeting Details:

The committee will discuss a possible association between vaginal douching and adverse consequences. FDA is aware of a number of case-control epidemiologic studies in the literature that suggest a possible association between vaginal douching and several conditions, such as pelvic inflammatory disease, ectopic pregnancy, and cervical cancer (letter from D. Bowen, FDA, to R. W. Soller, Nonprescription Drug Manufacturers Association, LET 105, Docket No. 75N-0183, Dockets Management Branch). The committee's discussion will include issues relating to behavioral, epidemiological, and microbiological aspects of vaginal douching. Regulatory issues related to over-the-counter vaginal-douche drugs, cosmetics, and devices (douching equipment) will also be addressed.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs - Dental Products Panel Plaque Subcommittee

Meeting Date: 6/6/96-6/7/96

Meeting Details:

The committee reviewed information on ingredients contained in products bearing anti-plaque and anti-plaque-related claims to determine whether these products are safe and effective and not misbranded for their labeled use.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs Advisory Committee With Representation From the Drug Abuse Advisory Committee

Meeting Date: 4/19/96-4/19/96

Meeting Details:

The committee will discuss new drug application (NDA) 20-536, Nicotrol (nicotine transdermal system, Pharmacia Upjohn/McNeil Consumer Products) indicated as an aid to smoking cessation for the relief of nicotine withdrawal symptoms, to switch from prescription to over-the-counter status; and supplemental NDA 20-165/S-011 Nicoderm (nicotine patch, Hoescht Marion Roussel/Alza Corp.), indicated as an aid to smoking cessation for the relief of nicotine withdrawal symptoms, to switch from prescription to over-the-counter status.

 

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

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

Meeting Details:

Nonprescription Drugs Advisory Committee will discuss issues raised during the Public Hearing before the Commissioner on Over-The-Counter Drug Labeling held earlier during the same day.

 

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

Meeting Date: 1/13/95-1/13/95

Meeting Details:

The committee will discuss pediatric dosing for children ages under 12 years.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsDental Products Panel Plaque Subcommittee (Nonprescription Drugs)

Meeting Date: 12/5/94-12/7/94

Meeting Details:

The subcommittee will continue with its discussions held during the October 11, 1994, and June 28 and 29, 1994, meetings as follows: (1) The possible relationship of alcohol- containing mouthwashes to the development of oral and pharyngeal cancers, (2) the drug/cosmetic status of antiplaque products and claims, and (3) work on developing general guidelines for determining the safety and effectiveness of antiplaque and antiplaque-related drug products. The committee will also work on a draft document to be presented at a joint meeting of the Dental Drug Products Panel and the Dental Drug Products Panel Plaque Subcommittee on December 6, 1994 (see meeting announcement elsewhere in this issue of the Federal Register).

 

       
Location: December 5 and 7, 1994, 9 a.m., Renaissance Hotel at Tech World, Salons A and B of the Renaissance Ballroom, 999 Ninth St. NW., Washington, DC. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDental Products Panel Plaque Subcommittee (Nonprescription Drugs)

Meeting Date: 10/11/94-10/11/94

Meeting Details:

The subcommittee will continue with its discussions held during the June 28 and 29, 1994, meeting as follows: (1) The possible relationship of alcohol-containing mouthwashes to the development of oral and pharyngeal cancers, and (2) work on developing general guidelines for determining the safety and effectiveness of antiplaque and antiplaque-related drug products. The subcommittee will also work on a draft document to be presented to the Dental Products Panel at a future meeting.

 

       
Location: October 11 and 12, 1994, 9 a.m., Holiday Inn--Silver Spring, International Ballroom, 8777 Georgia Ave., Silver Spring, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs

Meeting Date: 7/27/94-7/27/94

Meeting Details:

The committee will discuss the new drug application (NDA) 19-501, The Upjohn Co., to switch Rogaine (minoxidil 2% topical solution) for use as a hair growth stimulant for persons with androgenetic alopecia, from prescription to over-the- counter marketing status.

 

       
Location: July 27, 1994, 2 p.m., Parklawn Bldg., conference rms. D and E, FDA 5600 Fishers Lane, Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDental Products Panel Plaque Subcommittee (Nonprescription Drugs)

Meeting Date: 6/28/94-6/29/94

Meeting Details:

N/A

 

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

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic and Analgesic with DSRM

Meeting Date: 9/10/15-9/10/15

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Meeting Details:

The committees will be asked to discuss new drug application (NDA) 206830, oxycodone immediate-release tablets, submitted by Purdue Pharma, with the proposed indication of the management of moderate to severe pain where the use of an opioid analgesic is appropriate. It has been formulated with the intent to provide abuse-deterrent properties. The pharmacokinetic data demonstrate that there is a significant food effect resulting in a significant delay in absorption and peak plasma concentration of oxycodone when taken with food. The applicant proposes to address this finding by labeling the product to be taken on an empty stomach, but patients may have difficulty complying with these instructions as the product is dosed every 4 to 6 hours as needed. The committees will be asked to discuss the potential safety risks and the potential effects on efficacy associated with the delayed peak concentration when taken with food, and the feasibility of labeling to be taken an empty stomach as a means to mitigate the potential risks. The committees will also be asked to consider whether the potential public health benefit of the product’s abuse-deterrent properties are sufficient to outweigh the risk to patients who are prescribed the product for the management of pain.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic and Analgesic with DSRM

Meeting Date: 9/11/15-9/11/15

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Meeting Details:

The committees will discuss new drug application (NDA) 208090, oxycodone extended-release capsules for oral use, submitted by Collegium Pharmaceuticals, proposed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative options are inadequate. This product has been formulated with the intent to provide abuse-deterrent properties. Pharmacokinetic data demonstrate that, in order to deliver the intended amount of oxycodone, the drug product must be taken with food. The committees will be asked to discuss the potential safety risks and the potential effects on efficacy associated with the extent of the food effect, and potential fluctuations in oxycodone levels that may occur if the product is not taken consistently with the same amount of food. In addition, the committees will be asked to review and discuss whether the data characterizing the abuse-deterrent properties support the likelihood that this drug product will have a meaningful effect on abuse and whether potential benefits to the public from abuse-deterrent properties outweigh potential risks to patients from the effect of food. The committees will be asked to vote on whether this product should be approved for marketing in the United States.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory

Meeting Date: 9/15/15-9/15/15

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Meeting Details:

The committee will meet in open session to discuss and make recommendations on the safety and immunogenicity of Seasonal Trivalent Influenza Vaccine, Surface Antigen, Inactivated, Adjuvanted with MF59 (FLUAD) manufactured by Novartis.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 9/16/15-9/16/15

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Meeting Details:

On Wednesday, September 16, 2015, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by The Food and Drug Administration Safety and Innovation Act (FDASIA), for DUREZOL (difluprednate ophthalmic emulsion) 0.05%, Phenylephrine Hydrochloride Ophthalmic Solution, ZYLET (loteprednol etabonate and tobramycin ophthalmic suspension), BETHKIS (tobramycin Inhalation Solution), INTELENCE (etravirine), PREZISTA (darunavir), VIRAMUNE XR (nevirapine), EPIDUO (adapalene and benzoyl peroxide), EXJADE (deferasirox), DOTAREM (gadoterate meglumine), FYCOMPA (perampanel), RECOTHROM (thrombin, topical [recombinant]), PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). As mandated by the Food and Drug Administration Amendments Act, Title III, Pediatric Medical Device Safety and Improvement Act of 2007 (Public Law 110– 85), the committee will discuss the safety of and the ongoing propriety of the humanitarian device exemption for the PLEXIMMUNE, ELANA SURGICAL KIT (HUD), Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD), ENTERRA™ Therapy System, and CONTEGRA Pulmonary Valved Conduit.

 

       
Location: Double Tree by Hilton 8727 Colesville Road Silver Spring, MD 20910 Related News Links: Not Available
Time: 8:00AM-6:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 9/24/15-9/24/15

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Meeting Details:

On September 24, 2015, the committee will discuss the risks and benefits of Bayer HealthCare’s Essure System for permanent female sterilization. The system, originally approved in November 2002, under P020014, consists of a delivery system and nickel-containing permanent implants. The implants are placed without a skin incision, through the vagina, within each fallopian tube; they elicit tissue ingrowth, which over time results in tubal occlusion.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsArthritis AdComm

Meeting Date: 10/23/15-10/23/15

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Meeting Details:

The committee will discuss new drug application (NDA) 207988, lesinurad oral tablets, submitted by Ardea Biosciences, Inc., for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsBone, Reproductive and Urologic Drugs AdComm

Meeting Date: 11/3/15-11/3/15

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Meeting Details:

The committee will discuss new drug application (NDA) 207959, enclomiphene citrate 12.5 milligram (mg) and 25 mg capsules, submitted by Repros Therapeutics, Inc., for the proposed treatment of secondary hypogonadism in fertile men (men with more than 15 million sperm/milliliter (ml)), younger than 60 years of age with a Body Mass Index (BMI) over 25 kilograms (kg)/meters squared (m2).

 

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

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