FDA News & Notes - Week of June 27, 2011

SILVER SPRING, Md., June 27, 2011 /PRNewswire-USNewswire/ -- Science, public health, and regulatory highlights from the U.S. Food and Drug Administration. Information in this document is designed for credentialed journalists. Release dates and times for items are current as of June 27, 2011.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

FDA News & Notes does not contain any regulatory or enforcement actions due to legal limitations.

Events and Speeches for the Commissioner and FDA leadership:

Tuesday, 6/28 – FDA Commissioner Margaret A. Hamburg delivers a speech, "It Takes a Village – The Biotechnology Innovation Ecosystem," at the 2011 BIO International Convention. 3:45 p.m., Walter E. Washington Convention Center, 801 Mt. Vernon Place NW, Room 147 AB, Washington, D.C.

Press Office Contact: Jeff Ventura, 301-796-2807, [email protected]

Meetings, Workshops and Congressional Testimony:

Tuesday, 6/28, and Wednesday, 6/29 – Hearing on Proposal to Withdraw Approval for the Breast Cancer Indication for Bevacizumab (Avastin). The FDA is granting a hearing to Genentech Inc. on the Center for Drug Evaluation and Research's (CDER) proposal to withdraw accelerated approval of the breast cancer indication for bevacizumab (Avastin). Genentech and CDER are the parties to the hearing, which will take place in the Great Room of Building 31, FDA's White Oak campus. 

The hearing begins at 8 a.m. Tuesday with two hours of public comments followed by CDER's presentation. Wednesday features Genentech's presentation and a discussion and vote by the Oncologic Drugs Advisory Committee. Note: The final decision will be made by FDA Commissioner Margaret A. Hamburg at a later date.

Reporters are urged to register ahead of time with the press office. The press officer handling logistical questions and press registration is Karen Riley, [email protected], 301-796-4674. For questions involving CDER, contact Erica Jefferson in the press office, [email protected], 301-796-4988.

The White Oak campus is located at 10903 New Hampshire Ave., Silver Spring, Md., 20993. Please enter through Building One. Broadcast news outlets using a cart for their equipment must enter through the loading dock behind Building 51. Contact Karen Riley for additional logistical information. 

For more information:

http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm255874.htm

Press Office Contacts: Karen Riley, 301-796-4674, [email protected] (logistics)

Erica Jefferson, 301-796-4988, [email protected] (product data and status)

Wednesday, 6/29 – The Cellular, Tissue and Gene Therapies Advisory Committee discusses cellular and gene therapy products for the treatment of retinal disorders. 8 a.m., Crowne Plaza Hotel, 8777 Georgia Ave., Silver Spring, Md.

Press Contact: Paul Richards, 301-827-2000, [email protected]

Wednesday, 6/29 – The Microbiology Devices Panel of the Medical Devices Advisory Committee makes recommendations on the possible reclassification of molecular diagnostics for the rapid detection of Mycobacterium tuberculosis complex and the detection of genetic mutations that confer antibiotic resistance in M. tuberculosis. 8 a.m., Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, Md.

Press Office Contact: Amanda Sena, 301-796-0393, [email protected]

On the Web:

Draft Guidance for Industry and Food and Drug Administration Staff – Applying Human Factors and Usability Engineering to Optimize Medical Device Design  Recommendations intended to improve the usability of medical devices and reduce errors, injuries, and recalls associated with device use.

Press Office Contact: Karen Riley, 301-796-4674, [email protected]

FDA Office of Public Affairs Contact Information:

Call or email FDA Office of Public Affairs, 301-796-4540, [email protected]

List of FDA press officers and beats

More Resources:

FDA News and Events

FDA Photos (Flickr)

Consumer Health Information

SOURCE U.S. Food and Drug Administration

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