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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs Advisory Committee

Meeting Date: 7/19/16-7/19/16

Meeting Details:

The committee will discuss biologics license application (BLA) 761032, brodalumab injection, a human monoclonal antibody, submitted by Valeant Pharmaceuticals Luxembourg S.à.r.l, proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

 

       
Location: FDA White Oak 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: 3/9/15-3/9/15

Meeting Details:

During the morning session, the committee will discuss new drug application (NDA) 206333, deoxycholic acid injection, a cytolytic drug, submitted by Kythera Biopharmaceuticals, proposed for the improvement in the appearance of moderate-to-severe convexity or fullness associated with submental fat in adults. During the afternoon session, the committee will discuss pediatric development of systemic products for the treatment of atopic dermatitis with inadequate response to topical prescription therapy.

 

       
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: 2/24/15-2/24/15

Meeting Details:

The committees will discuss new drug application (NDA) 203324, for riboflavin ophthalmic solutions with UV-A irradiation, submitted by Avedro, Inc. The combination products are used in corneal collagen cross-linking and proposed to be indicated for the treatment of progressive keratoconus or corneal ectasia following refractive surgery.

 

       
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: 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 Advisory Committee

Meeting Date: 3/29/17-3/29/17

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Meeting Details:

During the morning session of March 29, 2017, the committee will discuss biologics license application (BLA) 761064, rituximab/hyaluronidase injection for subcutaneous use, submitted by Genentech, Inc. The proposed indications (uses) for this product are for: (1) The treatment of patients with relapsed or refractory, follicular lymphoma as a single agent; (2) previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab/hyaluronidase for subcutaneous injection in combination with chemotherapy, as single-agent maintenance therapy; (3) nonprogressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy; (4) the treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL) in combination with cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP) or other anthracycline based chemotherapy regimens; and (5) in combination with fludarabine and cyclophosphamide (FC), for the treatment of patients with previously untreated and previously treated chronic lymphocytic leukemia (CLL). During the afternoon session, the committee will discuss new drug application (NDA) 209099, for binimetinib, submitted by Array BioPharma Inc. The proposed indication (use) for this product is for the treatment of patients with unresectable or metastatic melanoma, with NRAS Q61 mutation as detected by an FDA-approved test, who have received prior treatment with checkpoint inhibitor therapy.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting Nonprescription AdComm & DSRM AdComm

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

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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 OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Anesthetic and Analgesic Drug Products AdComm and DSRM AdComm

Meeting Date: 4/5/17-4/5/17

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Meeting Details:

The committees will discuss new drug application (NDA) 209777, for oxycodone hydrochloride immediate-release oral tablets, submitted by Inspirion Delivery Sciences, LLC., with the proposed indication of management of moderate to severe pain where the use of an opioid analgesic is appropriate. The product has been formulated with properties intended to deter abuse, and the applicant has submitted data to support these abuse-deterrent properties for this product. The committees will be asked to discuss the overall risk-benefit profile of the product, and whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling.

 

       
Location: Tommy Douglas Conference Center Related News Links: Not Available
Time: 9:15AM-5:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Ophthalmic Devices Panel of the Medical Devices AdComm and the RC AdComm

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

Meeting Details:

On March 17, 2017, the committee will discuss and make recommendations regarding the potential risks of misuse of peroxide-based contact lens products.  Specific issues to be discussed include adequate labeling and packaging of these over-the-counter products.

 

       
Location: tbd Related News Links: Not Available
Time: 7:30AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology AdComm

Meeting Date: 3/15/17-3/15/17

Meeting Details:

The use of model-informed drug development (MIDD) for new and generic drugs has significantly increased over the past several years. The committee will discuss strategies, approaches, and challenges in MIDD with specific focus on two areas. During the morning session, the committee will discuss approaches and evidentiary information needed for applying physiologically-based pharmacokinetic modeling and simulation throughout a drug’s lifecycle. During the afternoon session, the committee will discuss mechanistic model-informed safety evaluation with a focus on drug potential for causing arrhythmias. The Comprehensive in Vitro Proarrhythmia Assay will be discussed as an exemplar.

 

       
Location: Omni Shoreham Hotel The Ballroom 2500 Calvert Street, NW Washington, DC 20008 Related News Links: Not Available
Time: 7:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the DSRM AdComm and the Anesthetic and Analgesic Drug Products AdComm

Meeting Date: 3/13/17-3/14/17

Meeting Details:

The committees will be asked to discuss safety issues for new drug application (NDA) 201655, OPANA ER (oxymorphone hydrochloride) Extended-release Tablets, by Endo Pharmaceuticals Inc., with the indication of management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is an approved extended-release (ER) formulation intended to have abuse-deterrent properties based on its physicochemical properties, however, this information is not currently reflected in product labeling. The committees will be asked to discuss pre- and post-marketing data about the abuse of OPANA ER, and the overall risk-benefit of this product. The committees will also discuss abuse of generic oxymorphone ER and oxymorphone immediate-release (IR) products.

 

       
Location: tbd Related News Links: Not Available
Time: 9:15AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee Meeting

Meeting Date: 3/6/17-3/7/17

Meeting Details:

On Monday, March 6, 2017, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by The Food and Drug Administration Safety and Innovation Act (FDASIA), for NITROPRESS (sodium nitroprusside), KUVAN (sapropterin dihydrochloride) and TRUVADA (emtricitabine/tenofovir disoproxil fumarate). On Tuesday, March 7, 2017, as mandated by the Food and Drug Administration Amendments Act, Title III, Pediatric Medical Device Safety and Improvement Act of 2007 (Public Law 110– 85), the committee will discuss the safety of and the ongoing propriety of the humanitarian device exemption for: EPICEL (cultured epidermal autografts) (HDE), IMPELLA RP SYSTEM (HDE), LIPOSORBER LA-15 SYSTEM (HDE), MEDTRONIC ACTIVA DYSTONIA THERAPY (HDE).

 

       
Location: Double Tree Silver Spring Related News Links: Not Available
Time: 8:30AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the Medical Devices AdComm

Meeting Date: 2/23/17-2/23/17

Meeting Details:

On February 23, 2017, the committee will discuss and make recommendations on clinical information related to the de novo request for the Sentinel® Cerebral Protection System, a first of a kind embolic protection device to be used with transcatheter aortic valve replacement (TAVR) procedures.

 

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

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