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Focus Group Info Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA sends a proposed collection of information on FDA focus groups to the Office of Management and Budget...

Pediatric Committee to Hear AER, Lactation Updates

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Federal Register Notice: FDAs Pediatric Advisory Committee will meet 11/27-28 to discuss adverse event reports on Tamiflu, Sereven...

FDA Clears Langfords Manzi Device Cleaner

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FDA clears a Langford IC Systems 510(k) for the Manzi Mach 1 Cleaner-Processor, a parametric-release liquid chemical instrument pr...

Noninferiority Studies Guidance Out

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FDA issues a guidance to explain appropriate clinical study designs to evaluate antibacterial drugs.

Europeans Look Online for Health Info

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A Manhattan Research white paper says drug companies should make better use of local Web sites in Europe to bring information to c...

FDA Guide on Dietary Supplement AE Reporting

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A new draft guidance for dietary supplement makers outlines adverse event reporting requirements that were mandated by last years ...

Public Workshop on Cell/Scaffold Products

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Federal Register Notice: CBER, CDRH, and the National Institute of Standards and Technology plan a public workshop 12/6-7 on in vi...

FDA Probing Employee Religious Pay

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FDA tells the Washington Post it is investigating employee misuse of religious compensation time that was converted to cash.

FDA Developing Import Agreements with China

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FDA commissioner Andrew von Eschenbach says the U.S. will soon sign import memoranda of agreement with China.

Device User Fees for FY 08

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Federal Register Notice: FDA publishes fee rates and payment procedures for medical device user fees for FY 2008.