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Taxotere Not Withdrawn for S&E

[ Price : $8.95]

Federal Register Notice: FDA determines that Taxotere injection, 40 mg/mL was not withdrawn from sale for safety or effectiveness ...

FDA Withdraws NDA for Mylotarg

[ Price : $8.95]

Federal Register Notice: FDA withdraws approval of a Wyeth NDA for Mylotarg for injection.

Guidance on Anticoccidial Drugs in Food-producing Animals

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Federal Register Notice: FDA releases a draft guidance, Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Anim...

Info on FDA Recall Regs Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on FDA recall regulations to the Office of Management an...

Docket Number Corrected in Device Workshop Notice

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Federal Register Notice: FDA corrects a docket number in an 11/7 notice announcing a public workshop on life cycle approaches for ...

Panel to Discuss Dissolvable Tobacco Products

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Federal Register Notice: FDAs Tobacco Products Panel will meet 1/18-20/12 to discuss dissolvable tobacco products.

FDA OKs Transcepts Intermezzo for Insomnia

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FDA approves Transcept Pharmaceuticals Intermezzo for use by people who waken in the middle of the night and have difficulty retur...

FDA Seeks Injunction Against Dietary Supplement Firm

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FDA asks for a permanent injunction against a Pennsylvania dietary supplement manufacturer and distributor and their owner.

More Clinical Trial Transparency Urged

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A Yale professor and co-authors propose making participant-level clinical trial data available for independent analysis to improve...

Responsible Corporate Officials Should be Vigilant: Attorneys

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Barnes & Thornburg attorneys say officials in regulated industries must act to prevent and correct any violations of federal law t...