U.S. FDA advisory meetings through Aug 3

Tue Jul 5, 2011 3:04pm EDT

THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION UPDATES ITS SCHEDULE. ALL ITEMS EDT/GMT.

For more information on the FDA's Advisory Committee meetings, see: here (Adds Aug. 2-3 blood products meeting)

ONCOLOGIC DRUGS ADVISORY COMMITTEE

DATE: July 14, 0800/1200

LOCATION: FDA White Oak Campus, Building 31, The Great Room (Rm. 1503), 10903 New Hampshire Ave., Silver Spring, Md.

CONTACT: Caleb Briggs, 301-796-9001

The committee will discuss the biologics license application from Seattle Genetics (SGEN.O) for Adcetris (brentuximab vedotin). The morning session will discuss the proposed use for treatment of Hodgkin's lymphoma (HL) that has relapsed or is resistant to previous treatments. The afternoon session will discuss the proposed indication for the treatment of relapsed or refractory systemic anaplastic large cell lymphoma (ALCL).

ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY COMMITTEE

DATE: July 19, 0800/1200

LOCATION: Hilton Washington DC/Silver Spring, the Ballrooms, 8727 Colesville Rd., Silver Spring, Md.

CONTACT: Paul Tran, 301-796-9001

The committee will discuss a new drug application from Bristol-Myers Squibb (BMY.N) and AstraZeneca (AZN.L) for dapagliflozin. It is the first drug in the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors, developed as an addition to diet and exercise in order to improve glycemic control in adults with type 2 diabetes mellitus.

CIRCULATORY SYSTEM DEVICES PANEL

DATE: July 20-21, 0800/1200

LOCATION: Hilton Washington DC North/Gaithersburgh, 620 Perry Pkwy., Gaithersburg, Md.

CONTACT: James Swink, 301-796-6313

On July 20, the committee will discuss the premarket approval application for Edwards Lifesciences' (EW.N) for the Edwards Sapien Transcatheter Heart Valve. On July 21, the committee will discuss the humanitarian device exemption for Berlin Heart's Excor Pediatric Ventricular Assist Device (VAD). The device is a pneumatically-driven extracorporeal VAD designed to provide bridge-to-transplant mechanical support to the heart.

GASTROINTESTINAL DRUGS ADVISORY COMMITTEE

DATE: July 21, 0800/1200

LOCATION: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, Md.

CONTACT: Kristine Khuc, 301-796-9001

The committee will discuss the results from a clinical trial of a supplement biologics license application from Centocor Ortho Biotech Inc., a unit of Johnson & Johnson (JNJ.N), for REMICADE (infliximab) for the treatment of pediatric patients with moderately to severely active ulcerative colitis.

TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE

DATE: July 21, 0900/1300; July 22, 0800/1200

LOCATION: Center for Tobacco Products, 9200 Corporate Blvd., Rockville, Md.

CONTACT: Caryn Cohen, 877-287-1373

On the morning of July 21, the committee will discuss changes proposed by committee members to the TPSAC Menthol Report submitted to the agency on March 18, 2011. On the afternoon of July 21 and on July 22, the committee will discuss the nature and impact of the use of dissolvable tobacco products on the public health. This discussion will begin the process for the committee's required report to the Secretary of Health and Human Services about this issue.

PHARMACEUTICAL SCIENCE AND CLINICAL PHARMACOLOGY ADVISORY COMMITTEE

DATE: July 26, 0830/1230

LOCATION: FDA White Oak Campus, Building 31, The Great Room (Rm. 1503), 10903 New Hampshire Ave., Silver Spring, Md.

CONTACT: Yvette Waples, 301-796-9001

The committee will discuss presentations by the Office of Generic Drugs (OGD) on bioequivalence issues and quality standards relative to narrow therapeutic index (NTI) drug products as a class. In response to feedback during its April 13, 2010 meeting, the committee will further discuss the definition and list of NTI drugs, as well as proposed bioequivalence standards for these products. The committee will also receive awareness presentations relevant to OGD's ongoing focus on quality and safety of generic drug products.

PHARMACEUTICAL SCIENCE AND CLINICAL PHARMACOLOGY ADVISORY COMMITTEE

DATE: July 27, 0830/1230

LOCATION: FDA White Oak Campus, Building 31, The Great Room (Rm. 1503), 10903 New Hampshire Ave., Silver Spring, Md.

CONTACT: Yvette Waples, 301-796-9001

The committee will discuss current strategies for the FDA's Office of Pharmaceutical Science implementation of Quality by Design principles within its review offices, incorporating an update on the activities of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. It will also receive awareness presentations on FDA's current partnering with the U.S. Pharmacopeia, principally to discuss the Monograph Modernization Program.

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE

DATE: Aug. 1, 0900/1300

LOCATION: Hilton Washington DC/North, 620 Perry Pkwy., Gaithersburg, Md.

CONTACT: Bryan Emery or Rosanna Harvey, 301-827-1277

The committee will discuss donor deferral for time spent in Saudi Arabia to reduce the risk of variant Creutzfeldt-Jakob disease (vCJD) by blood and blood products and human cells, tissues and cellular and tissue-based products.

BLOOD PRODUCTS ADVISORY COMMITTEE

DATE: Aug. 2, 1330/1730; Aug. 3 0800/1200

LOCATION: Hilton Washington DC/North, 620 Perry Pkwy., Gaithersburg, Md.

CONTACT: Bryan Emery or Rosanna Harvey, 301-827-1277

On Aug. 2, the committee will discuss a study on the incidence of Trypanosoma cruzi infection in blood donors and its implications for selective testing of blood donors. On Aug. 3, the committee will discuss measures to preserve the blood supply during a severe emergency. (Reporting by Anna Yukhananov and Alina Selyukh; Editing by Tim Dobbyn)

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