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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 7/26/12-7/26/12

Meeting Details:

During the morning session, the committee will discuss a supplement to biologics license application (BLA) 125156 for LUCENTIS (ranibizumab) injection by Genentech, Inc., for the treatment of diabetic macular edema (DME). Ranibizumab injection is currently approved for the treatment of neovascular (wet) age-related macular degeneration (AMD) and macular edema following retinal vein occlusion (RVO). During the afternoon session, the committee will discuss new biologics license application (BLA) 125422, ocriplasmin intravitreal injection (proposed tradename, Jetrea) by ThromboGenics, Inc., indicated for the treatment of symptomatic vitreomacular adhesions (sVMA) including macular hole.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 2/27/12-2/27/12

Meeting Details:

The committee will be asked to comment on the following topics related to the use of ophthalmic drug products (products intended for use in the eye): 1) Appropriate types of clinical evidence for developing anti-inflammatory drugs for the treatment of postoperative inflammation and reduction of ocular (eye) pain in patients who have undergone ocular surgery. This will include a discussion of the definition and scope of this indication as well as the types of clinical trials needed to support approval; and 2) appropriateness of marketing a single bottle of 3 ophthalmic product for use in both eyes for postsurgical indications as it relates to the potential risk for infection. FDA's Center for Drug Evaluation and Research would like the advisory committee to provide advice on the potential risk and approaches to mitigating that risk, including limits to fill size where appropriate.

 

       
Location: Hilton Washington DC/Silver Spring Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsEYLEA by Regeneron - Dermatologic and Ophthalmic Drugs AdComm

Meeting Date: 6/17/11-6/17/11

Meeting Details:

On June 17, 2011, the committee will discuss biologics license application (BLA) 125387, aflibercept ophthalmic solution, proposed trade name EYLEA, sponsored by Regeneron Pharmaceuticals, Inc., indicated for the treatment of neovascular age-related macular degeneration (wet AMD).

 

       
Location: UMUC Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCANCELLED - Dermatologic and Ophthalmic Drugs AdComm

Meeting Date: 6/28/10-6/28/10

Meeting Details:

On June 28, 2010, the committee will discuss new drug application (NDA) 22340, voclosporin 10-milligram capsules, by Lux Biosciences, Inc. The proposed indication for this new drug product is treatment of noninfectious uveitis involving the posterior or intermediate segments of the eye.

 

       
Location: Sheraton Washington Beltsville, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 6/26/09-6/26/09

Meeting Details:

On June 26, 2009, the committee will discuss two different new drug applications (NDAs), NDA 22–288, BEPREVE (bepotastine besilate) ophthalmic solution, 1.5%, ISTA Pharmaceuticals, Inc., proposed for the treatment of ocular itching associated with allergic conjunctivitis, and NDA 22–358, sodium hyaluronate ophthalmic solution, 0.18%, River Plate Biotechnology, Inc., proposed for the treatment of the signs and symptoms of dry eye disease.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 12/5/08-12/5/08

Meeting Details:

The committee will discuss new drug application (NDA) 22-308, besifloxacin ophthalmic solution, Bausch & Lomb, Inc., proposed for the treatment of bacterial conjunctivitis and NDA 22-369, bimatoprost ophthalmic solution, 0.03%, Allergan, Inc., proposed for the treatment of hypotrichosis of the eyelids.

 

       
Location: Hilton Washington DC/Rockville Rockville Pike, Rockville, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 6/17/08-6/18/08

Meeting Details:

On June 17, 2008, the committee will discuss biologic licensing application (BLA) 125261, ustekinumab, a human monoclonal antibody, Centocor, Inc., proposed for the treatment of moderate to severe psoriasis. On June 18, 2008, the committee will discuss supplemental biologic licensing application (sBLA) 10379515350, etanercept, a lyophilized powder for subcutaneous injection, Immunex Corp., proposed for the treatment of moderate to severe psoriasis in the pediatric population.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 5/29/08-5/29/08

Meeting Details:

The committee will discuss new drug application (NDA) 22-212, difluprednate ophthalmic emulsion, Sirion Therapeutics, Inc., proposed for the treatment of inflammation and pain following ocular surgery.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting on iPLEDGE

Meeting Date: 8/1/07-8/1/07

Meeting Details:

The committees will meet in joint session to be briefed on iPLEDGE, the risk management program for isotretinoin products. Presentations will provide updates on risk management activities for isotretinoin since the full implementation of iPLEDGE on March 1, 2006.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-12:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Dermatologic and Ophthalmic Drugs & OTC AdComm

Meeting Date: 3/24/05-3/24/05

Meeting Details:

The committee will discuss what should be the necessary and sufficient safety database in order to evaluate the prescription (Rx) to over-the-counter (OTC) switch of topical corticosteroids, especially the database to evaluate the potential for hypothalamic, pituitary, adrenal (HPA) and growth suppression and other systemic and local adverse events.

 

       
Location: Hilton-GB, MD Related News Links: Not Available
Time: 8:00AM-5:25PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPfizer/Eyetech - Dermatologic and Ophthalmic AdComm

Meeting Date: 8/27/04-8/27/04

Meeting Details:

The committee will discuss new drug application (NDA) 21- 756, pegaptanib sodium injection (proposed tradename, Macugen) by Eyetech Pharmaceuticals, Inc., indicated for the treatment of exudative (wet) age-related macular degeneration.

 

       
Location: FDA Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsDrug Safety and Risk Management Advisory Committee

Meeting Date: 7/12/04-7/12/04

Meeting Details:

The committee will discuss new drug application (NDA) 21–701, proposed tradename TAZORAL (oral tazarotene) 1.5 milligram (mg) and 4.5 mg capsules, Allergan, Inc., proposed for the treatment of moderate to severe psoriasis, including risk management options to prevent fetal exposure.

 

       
Location: FDA Rockville, MD Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting Drug Safety and Risk Management and the Derm./Ophthalmic Drugs AdComm

Meeting Date: 2/26/04-2/27/04

Meeting Details:

The committee will discuss the following topics: (1) The effectiveness of the isotretinoin risk management program for the prevention of fetal exposure to ACCUTANE and its generic equivalents, and (2) consider whether changes to this isotretinoin risk management program would be appropriate

 

       
Location: Hilton Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs Advisory Committee

Meeting Date: 9/25/03-9/25/03

Meeting Details:

On September 25, the committee will discuss the steady designs of trials in the treatment of myopia.

 

       
Location: HOL - GB Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs Advisory Committee

Meeting Date: 9/9/03-9/10/03

Meeting Details:

On September 9, 2003 the committee will discuss Raptiva by Genentech Inc. to be used in the treatment of adults with moderate-to-severe plaque psoriasis. On September 10, the committee will discuss NDA 21-5276 Metvix by Photocure for the treatment of basal cell carcinoma.

 

       
Location: HOL - GB Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs Advisory Committee

Meeting Date: 3/17/03-3/17/03

Meeting Details:

The Committee will discuss NDA 21-414 Vitrase by ISTA Pharmaceuticals for the treatment of vitreous hemorrhage.

 

       
Location: Hol - GB Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs Advisory Committee

Meeting Date: 11/4/02-11/5/02

Meeting Details:

The committee will be making recommendation for a developement of a proposed draft guidance concerning the development of products for mild to moderate acne.

 

       
Location: BHOL Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs

Meeting Date: 5/23/02-5/23/02

Meeting Details:

Biogen, Inc. announced that the U.S. Food and Drug Administration (FDA) will convene a Dermatologic and Opthalmic Drugs Advisory Committee on May 23, 2002 to review the registrational filing of Biogen's drug AMEVIVE (alefacept) for the treatment of moderate to severe chronic plaque psoriasis.

 

       
Location: Holiday Inn Silver Spring MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs

Meeting Date: 11/16/00-11/16/00

Meeting Details:

On November 16, 2000, the committee will discuss new drug application (NDA) 50-777, Protopic (tacrolimus ointment) Ointment, Fujisawa Healthcare, Inc., for short and long term treatment of the signs and symptoms of atopic dermatitis in adult and pediatric patients 2 years of age or older.

 

       
Location: Rockville, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs

Meeting Date: 9/18/00-9/19/00

Meeting Details:

On September 18 through 19, 2000, the committee will discuss: (1) NDA 18-662, Accutane (isotretinoin) Capsules, Hoffmann-LaRoche, Inc., for severe recalcitrant nodular acne; and (2) NDA 21-177, (new formulation) isotretinoin capsules, Hoffmann-LaRoche, Inc., for severe recalcitrant nodular acne.

 

       
Location: Holiday Inn Gaithersburg, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs

Meeting Date: 6/29/00-6/30/00

Meeting Details:

On June 29, 2000, during the initial open session, the committee will discuss NDA 20-010, Lotrisone Lotion (clotrimazole/betamethasone diproprionate), Schering-Plough, Inc., for the treatment of the tinea pedia, tinea cruris and tinea corporis, and NDA 20-996, Dermex II Ointment (zinc oxinate), Dermex Pharmaceuticals, LLC, for the treatment of actinic keratosis, basal cell carcinoma, and squamous cell carcinoma. On June 30, 2000, the committee will discuss NDA 21-026, (miconazole nitrate, USP 0.25%) oinment, Johnson & Johnson Consumer Companies, Inc. for the treatment of diaper dermatitis.

 

       
Location: Holiday Inn Bethesda, MD. Related News Links: Not Available
Time: 8:30AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs

Meeting Date: 11/17/99-11/17/99

Meeting Details:

The subcommittee will discuss new drug application (NDA) 21-119 Visudyne™ (verteporfin for injection, QLT Therapeutics, Inc.), for treatment of age-related macular degeneration (AMD) in patients with predominantly classic subfoveal choroidal neovascularization.

 

       
Location: Holiday Inn Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs

Meeting Date: 11/4/99-11/5/99

Meeting Details:

On November 4, 1999, during the morning session, the committee will discuss new drug application (NDA) 21-022, Loprox™(ciclopirox nail lacquer),Hoechst Marion Roussel, Inc., for treatment of onychomycosis. On November 4, 1999, during the afternoon session, the committee will participate in a scientific discussion of clinical trial design questions for products intended for the treatment of hand dermatitis. On November 5, 1999, during the afternoon session, the committee will discuss NDA 20-965, Levulan® (aminolevulinic acid HCL) Kerastick™ for Topical Solution, 20%, Dusa Pharmaceuticals, Inc., for use in the treatment of multiple actinic keratoses of the face and scalp.

 

       
Location: Gaithersburg Hilton Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs

Meeting Date: 7/21/99-7/21/99

Meeting Details:

The subcommittee will discuss new drug application (NDA) 21-023 (cyclosporine ophthalmic emulsion, 0.05%, Allergan, Inc.),for treatment of moderate to severe keratoconjunctivitis sicca. *** Call for Satellite, Videoconferencing and Webcasting ***

 

       
Location: Hilton Hotel Salons A and B 620 Perry Pkwy. Gai Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs

Meeting Date: 3/19/98-3/20/98

Meeting Details:

On March 19, 1998, the Committee will discuss generic topical dermatologicals draft guidance. On March 20, 1998, the Committee will participate in a scientific discussion of clinical trial design questions for products intended for the treatment of psoriasis.

 

       
Location: Holiday Inn, Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs Advisory Committee

Meeting Date: 11/13/97-11/14/97

Meeting Details:

On November 13, 1997, the committee will discuss new drug application (NDA) 20-788, PropeciaTM (finasteride 1 milligram tablets, Merck Research Laboratories), for treatment of androgenetic alopecia to increase hair growth and to prevent further hair loss. On November 14, 1997, the committee will participate in a scientific discussion of clinical trial design questions for products intended for the treatment of burn wounds. This is one segment of an overall effort by the agency to develop a guidance document on wound healing products.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs Advisory Committee

Meeting Date: 9/4/97-9/5/97

Meeting Details:

The committee will hear presentations and discuss data submitted regarding the new drug application (NDA) 20-785, SynovirTM (thalidomide capsules, Celgene Corp.), for treatment of erythema nodosum leprosum.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint meeting of the Nonprescription and the Dermatologic and Ophthalmic Drugs Advisory Committee

Meeting Date: 7/16/97-7/16/97

Meeting Details:

The committee will hear presentations and discuss data submitted regarding the over-the-counter status of new drug application (NDA) 20-834, Rogaine (minoxidil 5% topical solution), The Pharmacia & Upjohn Co. for use as a hair growth stimulant by men with androgenetic alopecia.

 

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

Meeting Date: 7/14/97-7/15/97

Meeting Details:

On July 14, 1997, the committee will discuss biologic licensing application (BLA) 96-1408, Regranex (becaplermin [PDGF-BB], Chiron Corp., in a carboxymethyl cellulose gel), OMJ Pharmaceuticals, Inc., for treatment of chronic diabetic foot ulcers. On July 15, 1997, the committee will participate in a general scientific discussion regarding the development of a possible future guidance document for chronic cutaneous ulcers. This is one segment of an overall effort by the agency to provide guidance on wound healing products, including a future discussion of products for treatment of burns. The agency encourages investigators, academicians, members of the pharmaceutical industry, consumer groups, and others with information relevant to the topics to respond to the contact person.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs Advisory Committee

Meeting Date: 4/17/97-4/17/97

Meeting Details:

On April 17, 1997, the committee will hear presentations and discuss the teratogenicity and labeling issues regarding approved NDA 19-821 for Soriatane (acitretin capsules, Hoffman-LaRoche, Inc.) for use in treating severe psoriasis.

 

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

Meeting Date: 11/7/96-11/8/96

Meeting Details:

On November 7, 1996, the committee will hear presentations and discuss the potential for neurotoxicity of thalidomide raised by the investigational use and possible eventual approval of thalidomide for dermatologic and other indications. On November 8, 1996, the committee will hear presentations and discuss the teratogenicity of thalidomide and issues of pregnancy prevention raised by the investigational use and possible eventual approval of thalidomide for dermatologic and other indications.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint OTC & Dermatologic & Ophthalmic Drugs

Meeting Date: 11/17/95-11/17/95

Meeting Details:

The committees will discuss data relevant to NDA 19-501 to switch Rogaine (minoxidil 2% topical solution, The Upjohn Co.), for use as a hair regrowth treatment for persons with androgenetic alopecia, from prescription to over-the- counter marketing status.

 

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

Meeting Date: 9/22/94-9/23/94

Meeting Details:

The committee will discuss onychomycosis and determination of endpoints for clinical trials investigating treatment of onychomycosis. Closed committee deliberations. On September 22, 1994, the committee will discuss trade secret and/or confidential commercial information relevant to pending investigational new drug applications.

 

       
Location: September 22 and 23, 1994, 8:30 a.m., Parklawn Bldg., conference rms. D and E, FDA 5600 Fishers Lane, Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Generic & Dermatologic Drugs

Meeting Date: 9/12/94-9/13/94

Meeting Details:

In April 1992, the Generic Drugs Advisory Committee met to consider methods for documenting the bioequivalence of topical corticosteroids. Subsequently, on July 1, 1992, the Office of Generic Drugs issued a guidance document entitled ``Interim Guidance for Topical Corticosteroids: In Vivo Bioequivalence and In Vitro Release Methods.'' The purpose of the September 1994 meeting is to reexamine the 1992 interim guidance in light of new experimental data and methods of analysis. On September 12, 1994, the committee will discuss the pharmacodynamic (i.e., vasoconstrictor) measurement of bioequivalence. On September 13, 1994, this topic will be further discussed along with other issues related to the documentation of equivalence according to the interim guidance. Discussion will be limited to dermatologic products and will not include ophthalmic or inhaled corticosteroid products. Also, on September 13, 1994, there will be a review of the current status of topics discussed at previous Generic Drugs advisory committee meetings

 

       
Location: September 12 and 13, 1994, 8:30 a.m., Parklawn Bldg., conference rms. G, H, I, and J, FDA 5600 Fishers Lane, Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 4/21/14-4/21/14

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Meeting Details:

On April 21, 2014, the Pediatric Advisory Committee (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 (Pub. L. 108–155). The PAC will meet to discuss Activa Dystonia Therapy, ADVATE (antihemophilic factor (recombinant)), FAMVIR (famciclovir), INTELENCE (etravirine), KEPPRA (levetiracetam), MAXALT and MAXALT MLT (rizatriptan), NATAZIA (estradiol valerate and estradiol valerate/dienogest), PERTZYE (pancrelipase), PERZISTA (darunavir), REYATAZ (atazanavir), SKLICE (ivermectin), TISSEEL (fibrin sealant), TORISEL (temsirolimus), ULTRESA (pancrelipase), Vertical Expandable Prosthetic Titanium Rib (VEPTR), and VIREAD (tenofovir disoproxil fumarate).

 

       
Location: Bethesda Marriott 5151 Pooks Hill Road Bethesda, MD 20814 Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drugs AdComm

Meeting Date: 4/22/14-4/22/14

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Meeting Details:

The committee will discuss the safety and efficacy for new drug application 203077, MOXDUO (morphine sulfate and oxycodone hydrochloride) capsules, QRxPharma Inc., for the proposed indication of management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. This product represents the first drug combination consisting of two immediate-release opioids.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 4/24/14-4/24/14

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Meeting Details:

On April 24, 2014, the committee will discuss the current knowledge about the safety and effectiveness of aversive conditioning devices that are intended to deliver a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics. FDA is convening this committee to seek clinical and scientific expert opinion on the risks and benefits of certain aversive conditioning devices based on available scientific data and information. The Agency is considering whether to ban aversive conditioning devices that are intended to administer a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics. The meeting will concern only devices classified under 21 CFR 882.5235 (aversive conditioning device, class II) that are not self-administered. Devices which deliver a noxious electrical stimulus automatically are not considered to be self-administered devices. Section 516 of the FD&C Act (21 U.S.C. 360f) sets forth the standard for banning devices. Under that provision, in order to ban a device, FDA must make a finding that a device "presents substantial deception or an unreasonable and substantial risk of illness or injury" based on all available data and information. FDA regulations provide additional details about the procedures and standards for banning a device (21 CFR part 895).

 

       
Location: Holiday Inn - Main Ballroom 2 Montgomery Village Ave. Gaithersburg, MD 20879 Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs AdComm

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

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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 OptionsMeeting OptionsMeeting OptionsRisk Communication AdComm

Meeting Date: 5/5/14-5/6/14

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Meeting Details:

On May 5-6, 2014, the Committee will meet to discuss methods for identifying the impact and increasing the reach of communications on topics of interest to consumers. The discussion will also address how FDA can evaluate whether its Consumer Updates (http://www.fda.gov/ForConsumers/ConsumerUpdates/default.htm disclaimer icon ) are reaching the targeted population, and whether they are increasing awareness and understanding of the key risk messages. The discussion will also assess whether the communications are having the intended impact on knowledge, behaviors and/or outcomes.

 

       
Location: The Great Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 5/6/14-5/7/14

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Meeting Details:

On May 6, 2014, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the RESQCPR System sponsored by Advanced Circulatory Systems, Inc. The RESQCPR System is comprised of two devices: the RESQPOD 16.0 Impedance Threshold Device, and the RESQPUMP Active Compression Decompression CPR Device. These devices are used together during manual cardiopulmonary resuscitation (CPR) in an attempt to enhance venous return to the heart and blood flow to vital organs during CPR to ultimately increase survival and neurologic outcome in patients suffering from out of hospital cardiac arrest. Advanced Circulatory Systems, Inc. has proposed the following indications for use: the RESQCPR System is intended for use in the performance of CPR to increase survival with favorable neurologic function in adult patients with non-traumatic cardiac arrest. On May 7, 2014, during session I, the committee will discuss and make recommendations regarding the classification of membrane lung for long-term pulmonary support systems, one of the remaining preamendment Class III devices regulated under the 510(k) pathway. A membrane lung for long-term pulmonary support refers to the oxygenator component of an extracorporeal circuit used during long-term procedures, commonly referred to as extracorporeal membrane oxygenation (ECMO). An ECMO procedure provides assisted extracorporeal circulation and physiologic gas exchange of a patient's blood when an acute (reversible) condition prevents the patient's own body from providing the physiologic gas exchange needed to sustain life. The circuit is comprised of multiple device types, including, but not limited to, an oxygenator, blood pump, cannulae, heat exchanger, tubing, filters, monitors/detectors, and other accessories; the circuit components and configuration (e.g., arteriovenous, veno-venous) may differ based on the needs of the individual patient or the condition being treated. ECMO is currently used for patients with acute reversible respiratory or cardiac failure, unresponsive to optimal ventilation and/or pharmacologic management.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 5/13/14-5/13/14

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Meeting Details:

On May 13, 2014, the committee will discuss and make recommendations regarding the guidance documents for contact lenses and contact lens accessories.

 

       
Location: Holiday Inn Germantown, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 4/1/14-4/1/14

Meeting Details:

The committee will discuss new drug application (NDA) 22-472, proposed trade name AFREZZA (TECHNOSPHERE Insulin Inhalation System), 3 unit and 6 unit cartridges for oral inhalation, manufactured by MannKind Corporation. The proposed indication (use) for this application is to improve glycemic control in adult patients with type 1 or type 2 diabetes mellitus.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs Advisory Committee

Meeting Date: 3/31/14-3/31/14

Meeting Details:

During the morning session, the committee will discuss new drug applications (NDAs) 205-435 and 205-436, tedizolid phosphate tablets and tedizolid phosphate injection, submitted by Trius Therapeutics, respectively, for the proposed indication of treatment of acute bacterial skin and skin structure infections. During the afternoon session, the committee will discuss NDA 021-883, dalbavancin hydrochloride for intravenous injection, submitted by Durata Therapeutics International B.V., for the proposed indication of treatment of acute bacterial skin and skin structure infections.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 3/27/14-3/27/14

Meeting Details:

The committee will discuss biologics license application 125468, serelaxin injection, submitted by Novartis, as a treatment to improve the symptoms of acute heart failure through reduction of the rate of worsening of heart failure.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMolecular and Clinical Genetics Panel

Meeting Date: 3/26/14-3/27/14

Meeting Details:

On March 26, 2014, the committee will discuss, make recommendations and vote on information related to the premarket approval application sponsored by Epigenomics, Inc. for the Epi proColon. The Epi proColon test is a qualitative in vitro diagnostic method for the detection of methylated Septin 9 DNA in plasma derived from patient whole blood specimens. Methylation of the target Septin 9 DNA sequence has been associated with the occurrence of colorectal cancer (CRC). The test is indicated to screen patients for CRC who are defined as average risk for CRC by current screening guidelines. The Epi proColon test is not intended to replace colorectal screening by colonoscopy. Patients with a positive Epi proColon test result should be referred for diagnostic colonoscopy. The Epi proColon test results are intended to be used in conjunction with the physician's assessment of history, other risk factors, and professional guidelines. On March 27, 2014, the committee will discuss, make recommendations and vote on information related to the premarket approval application for the Cologuard device, sponsored by Exact Sciences. Cologuard is an in vitro diagnostic device designed to analyze patients' stool for detection of hemoglobin, multiple DNA methylation and mutational markers, and the total amount of human DNA. Cologuard is intended for use as an adjunctive screening test for the detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer or premalignant colorectal neoplasia. Cologuard is not intended as a replacement for colonoscopy. Cologuard is intended to be used in conjunction with colonoscopy and other test methods in accordance with recognized screening guidelines.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 3/20/14-3/20/14

Meeting Details:

On March 20, 2014, the committee will discuss, make recommendations, and vote on information regarding the humanitarian device exemption (HDE) application for the XVIVO Perfusion System (XPSTM) sponsored by XVIVO Perfusion, Inc. The proposed Indication for Use for the XVIVO Perfusion System, as stated in the HDE, is as follows: The XPSTM is intended to be used with STEEN Solution for flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the function of the lungs can be reassessed for transplantation.

 

       
Location: Holiday Inn, GBurg Related News Links: Not Available
Time: 8:00AM-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.

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