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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting Nonprescription AdComm & DSRM AdComm

Meeting Date: 4/4/17-4/4/17

Meeting Details:

The committees will discuss safety issues associated with over-the-counter analgesic combination products used for upset stomach (i.e., heartburn, nausea, fullness, belching, gas, acid indigestion, and/or sour stomach) and hangover indications under the Internal Analgesic and Antacid monographs in 21 CFR part 343 and 21 CFR part 331, respectively. The committees will also be asked to discuss the hangover indication under the Overindulgence, Internal Analgesic, and Stimulant monographs in 21 CFR part 357 subpart J, 21 CFR part 343, and 21 CFR part 340, respectively.

 

       
Location: Tommy Douglas Conference Center Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs Advisory Committee Meeting

Meeting Date: 4/15/16-4/15/16

Meeting Details:

The committee will discuss data submitted by Galderma Laboratories, L.P. to support supplemental new drug application (sNDA) 20-380, for over-the-counter (OTC) marketing of adapalene gel 0.1%. The proposed OTC use is for the treatment of acne and to clear up acne pimples and acne blemishes. The applicant proposes to label the product for 12 years and older. The committee will be asked to consider whether data support an acceptable risk/benefit profile for the nonprescription use of adapalene gel 0.1% by OTC consumers.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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 OptionsArthritis AdComm

Meeting Date: 4/23/18-4/23/18

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Meeting Details:

The committee will discuss the new drug application (NDA) 207924, for baricitinib tablets, submitted by Eli Lilly and Company, for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The discussion will include the following: efficacy, safety, including the risk of thromboembolic adverse events, dose selection, and overall risk benefit considerations.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsArthritis and DSRM AdComm

Meeting Date: 4/24/18-4/25/18

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Meeting Details:

The committees will be asked to discuss supplemental new drug application (sNDA) 20998 for CELEBREX (celecoxib) capsules submitted by Pfizer, Inc., which includes the results from the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen) trial, a cardiovascular outcomes randomized controlled trial that compared celecoxib to ibuprofen and naproxen, and determine whether the findings of the trial change FDA’s current understanding of the safety of these three NSAIDs. In order to interpret some of the PRECISION findings, the committees will also consider the clinical implications of the drug interactions between each of these three NSAIDs and aspirin in patients taking aspirin for secondary prevention of cardiovascular disease.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 5/1/18-5/1/18

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Meeting Details:

The committee will discuss new drug application (NDA) 208627 for tecovirimat, sponsored by SIGA Technologies Inc., for the proposed indication of the treatment of smallpox disease caused by variola virus in adults and pediatric patients. This product was developed under the Animal Rule (21 CFR part 314, subpart I).

 

       
Location: FDA Meeting Room - Out of WO Related News Links: Not Available
Time: 10:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 5/2/18-5/2/18

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Meeting Details:

The committee will discuss new drug application (NDA) 210303 for plazomicin, sponsored by Achaogen, Inc., for the proposed indications for the treatment of complicated urinary tract infections and blood stream infections in adults.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastro and Pediatric AdComm

Meeting Date: 5/3/18-5/3/18

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Meeting Details:

The committees will discuss new drug application (NDA) 209904, for stannsoporfin injection, for intramuscular use, submitted by InfaCare Pharmaceutical Corporation, proposed for the treatment of neonates greater than or equal to 35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe hyperbilirubinemia.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 5/10/18-5/10/18

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Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 210645, for volanesoren solution for subcutaneous injection, submitted by Akcea Therapeutics, Inc. The proposed indication is as an adjunct to diet for the treatment of patients with familial chylomicronemia syndrome.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Analgesic with DSRM AdComm

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

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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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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs AdComm

Meeting Date: 4/19/18-4/19/18

Meeting Details:

The committee will discuss new drug application (NDA) 210365, cannabidiol oral solution, sponsored by GW Pharmaceuticals, for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-1:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsClinical Chemistry & Clinical Toxicology Devices Panel of the Medical Devices AdComm

Meeting Date: 3/29/18-3/30/18

Meeting Details:

On March 29, 2018, the committee will discuss, make recommendations, and vote on information regarding a premarket approval application to market a novel continuous glucose monitoring (CGM) device system, the Senseonics, Inc. Eversense CGM System. This device requires minor surgery to implant and remove, and if approved, would provide 90 days of sensor glucose values from each implanted sensor. The Eversense CGM System measures patients’ glucose concentrations from subcutaneous interstitial fluid similar to approved CGM systems. All CGM devices currently or previously marketed used electrochemistry to measure glucose in interstitial fluids, last for 3 to 11 days and are inserted via a small-gauge needle by the end user. The proposed CGM system uses a fluorescence-based measurement technique, requires minor surgery for subcutaneous implantation, and will have a 90-day sensor wear period. The proposed CGM sensor also includes a drug component (dexamethasone acetate) intended to mitigate negative effects on sensor accuracy and sensor life from the foreign body response at the sensor insertion site. The proposed intended use, as stated by the sponsor, is as follows: The Eversense CGM System continually measures glucose levels in adults (age 18 and older) with diabetes for the operating life of the sensor. The system is intended to: • Aid in the management of diabetes. • Provide real-time glucose readings. • Provide glucose trend information. • Provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia). The system is a prescription device. Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns seen over time. On March 30, 2018, the committee will discuss and make recommendations regarding measuring blood glucose using capillary blood with blood glucose meters in all hospital patients, including those receiving intensive medical intervention/therapy and patients with decreased peripheral blood flow, such as with severe hypotension, shock, hyperosmolar-hyperglycemia and severe dehydration (e.g., patients in intensive care settings). Currently, FDA has cleared one glucose meter for use all over the hospital using venous and arterial blood. FDA understands that being able to make capillary blood measurements in all hospitalized patients using FDA cleared and Clinical Laboratory Improvement Amendments (CLIA) waived (i.e., designated as waived per the standards in the CLIA) glucose meters would be more convenient and timely for hospital staff. FDA would like to present new data from capillary blood measurements on glucose meters in patients receiving intensive medical intervention/therapy to the Clinical Chemistry and Clinical Toxicology Devices Panel. FDA would like to receive feedback from the advisory panel on the benefits and risks of measuring capillary blood using blood glucose meters in this intended use population, and the considerations for CLIA waiver for this use.

 

       
Location: Hilton Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs AdComm

Meeting Date: 3/27/18-3/27/18

Meeting Details:

The committee will discuss new drug application (NDA) 209229, lofexidine hydrochloride, submitted by US WorldMeds, LLC, for mitigation of symptoms associated with opioid withdrawal and facilitation of completion of opioid discontinuation treatment.

 

       
Location: Tommy Douglas Conference Center 10000 New Hampshire Ave Silver Spring, MD 20903 Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 3/22/18-3/23/18

Meeting Details:

On Thursday, March 22, 2018, the Pediatric Advisory Committee (PAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) will meet to discuss the major objectives of a phase 3 drug development program indicated for the treatment of children with achondroplasia (ACH) submitted by BioMarin Pharmaceutical Inc. The following elements of a phase 3 program should be considered for discussion: evidence required to establish dose-response, study design, e.g., placebo control, study duration, intended population, e.g., infants and toddlers and/or older children and adolescents, and endpoints that have a clinically meaningful impact on the patient’s functional or psychological well-being. On Friday, March 23, 2018, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003. The Pediatric Advisory Committee will meet to discuss the following products (listed by FDA Center): 1) Center for Drug Evaluation and Research BANZEL, INTUNIV, LEXAPRO 2) Center for Devices and Radiological Health FLOURISH (HDE), ACTIVA (HDE), LIPOSORBER (HDE), IMPELLA RP SYSTEM (HDE)

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Past Meetings

Below is a listing of all committees. Select a committee to display all meetings available for that committee.

Live Meetings

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