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Meeting Date: 02/04/00

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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    
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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    
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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    
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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    
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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    
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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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Past Meetings

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

Live Meetings

There are no Live Broadcasts available at this time.