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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 10/20/14-10/20/14

Meeting Details:

The committee will discuss biologics license application (BLA) 125504, secukinumab, a human monoclonal antibody, submitted by Novartis, proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

 

       
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: 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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 1/7/15-1/7/15

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Meeting Details:

The committee will discuss biologics license application (BLA) 125553 for EP2006, a proposed biosimilar to Amgen Inc.'s NEUPOGEN (filgrastim), submitted by Sandoz, Inc. The proposed indications (uses) for this product are: (1) To decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever; (2) for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with acute myeloid leukemia; (3) to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by marrow transplantation; (4) for the mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis; and (5) for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.

 

       
Location: FDA - White Oak 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: 1/12/15-1/12/15

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Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 022517, proposed trade name NOCDURNA (established name: desmopressin), orally disintegrating sublingual tablets submitted by Ferring Pharmaceuticals, Inc. The proposed indication is treatment of nocturia due to nocturnal polyuria in adults who awaken two or more times each night to void.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs AdComm

Meeting Date: 1/22/15-1/22/15

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Meeting Details:

The committee will discuss new drug applications (NDAs) 207-500 and 207-501, isavuconazonium sulfate capsules and isavuconazonium sulfate for injection, sponsored by Astellas Pharma Global Development, Inc., respectively for the proposed indications of treatment of invasive aspergillosis and mucormycosis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsNew Date: Orthopaedic and Rehabilitation Devices Panel

Meeting Date: 2/20/15-2/20/15

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Meeting Details:

On February 20, 2015, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Superion InterSpinous Spacer device sponsored by Vertiflex Incorporated. The proposed Indication for Use for the Superion InterSpinous Spacer device, as stated in the PMA, is as follows: the Superion InterSpinous Spacer (the Superion ISS) is intended to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate lumbar spinal stenosis, with or without Grade 1 spondylolisthesis, confirmed by X-ray, MRI and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. The Superion ISS is indicated for those patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, numbness, and/or cramping, with or without back pain. The Superion ISS may be implanted at one or two adjacent lumbar (L) levels in patients in whom treatment is indicated at no more than two levels, from L1 to L5.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 3/4/15-3/4/15

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Meeting Details:

On March 4, 2015, from 8:30 a.m. to 3 p.m., the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2015-2016 influenza season.

 

       
Location: Hilton - Silver Spring, MD Related News Links: Not Available
Time: 8:30AM-3:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs AdComm - Cerexa Inc.

Meeting Date: 12/5/14-12/5/14

Meeting Details:

The committee will discuss new drug application (NDA) 206494 for ceftazidime-avibactam for injection, submitted by Cerexa Inc., for the proposed indications of: Complicated Intra-abdominal Infections, Complicated Urinary Tract Infections, including Acute Pyelonephritis and Limited Use Indication: Aerobic Gram-negative Infections with Limited Treatment Options.

 

       
Location: The Marriott Inn and Conference Center 3501 University Blvd. East, Hyattsville, Maryland 20783 Related News Links: Not Available
Time: 8:00AM-4:30AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs AdComm

Meeting Date: 12/4/14-12/4/14

Meeting Details:

The committee will discuss issues related to clinical development programs and clinical trial designs for antibacterial products for the treatment of patients with serious bacterial infections for which there are limited or no therapeutic options.

 

       
Location: The Marriott Inn and Conference Center 3501 University Blvd. East, Hyattsville, Maryland 20783 Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm

Meeting Date: 11/24/14-11/25/14

Meeting Details:

The committee will discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management. The committee will also consider the efficacy of ESI and the overall risk benefit balance of injecting steroids in the epidural space to treat pain. These considerations will assist the Agency in our discussions of possible regulatory options, including but not limited to changes to the product labeling.

 

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

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