April 23, 2007
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FDA Approves Generic Versions of Ambien to Treat Insomnia

FDA has approved the first generic versions of the insomnia drug Ambien (zolpidem tartrate). The agency has given 13 manufacturers approval to produce the generics.
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01616.html

Medical Products Seized from N.J. Company Due to Violations

FDA investigators and U.S. marshals have seized all implantable medical devices made by New Jersey-based Shelhigh Inc., after finding significant manufacturing deficiencies that may compromise the safety and effectiveness of the products, especially their sterility. Seized products include pediatric heart valves, surgical patches, and arterial grafts.
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01612.html

Minn. Seafood Marketer Agrees to Correct Food Safety Problems

Minneapolis-based Worldwide Fish & Seafood Inc. has entered into a court-approved agreement to correct violations in food and drug law. The agreement requires the company to develop an adequate Hazard Analysis and Critical Control Point (HACCP) plan for each of its seafood products. HACCP is a system for identifying possible safety problems and creating preventive measures to control potential hazards.
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01613.html

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CONGRESSIONAL TESTIMONY

April 19 -- FDA Center for Drug Evaluation and Research Director Steven K. Galson, M.D., appeared before the Senate Special Committee on Aging.

    Subject: "BioIdentical Hormones: Sound Science or Bad Medicine"

http://www.fda.gov/ola/2007/hormone041907.html April 18 -- FDA Center for Biologics Evaluation and Research Director Jesse L. Goodman, M.D., appeared before the House Subcommittee on Emerging Threats, Cybersecurity, and Science and Technology.

    Subject: "FDA's Role in the Regulation of Vaccines"

http://www.fda.gov/ola/2007/vaccines041807.html

April 17 -- FDA Assistant Commissioner for Planning Theresa M. Mullin, Ph.D., appeared before the House Subcommittee on Health

    Subject: the Prescription Drug User Fee Act

http://www.fda.gov/ola/2007/pdufa041707.html

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UPCOMING PUBLIC MEETINGS

April 24 -- Public meeting to obtain comments about the Animal Drug User Fee Act relative to the program's performance and reauthorization

    Location: Rockville, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-4452.htm

June 12-13 -- Public hearing to obtain feedback on FDA's Medication Guide program

    Location: Washington, D.C.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01606.html

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QUESTION OF THE WEEK

I'm scheduled to have an x-ray. What can be done to reduce my radiation risks and contribute to a successful procedure?

Some tips:

• Keep a "medical x-ray history" with the names of your radiological exams or procedures, the dates and places where you had them, and the physicians who referred you for those exams.
• Make your current healthcare providers aware of your medical x-ray history.
• Ask your healthcare provider about whether or not alternatives to x-ray exams would allow the provider to make a good assessment or provide appropriate treatment for your medical situation.
• Provide interpreting physicians and referring physicians with any recent x-ray images and radiology reports.
• Inform radiologists or x-ray technologists in advance if you are pregnant or think you may be pregnant.

For more information, see http://www.fda.gov/cdrh/radhealth/products/medicalxray.html.

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