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FDA Complete Response on MedImmune BLA

[ Price : $8.95]

FDA issues MedImmune a complete response letter on its BLA for motavizumab, indicated for preventing serious respiratory syncytial...

DDMAC Faults Actelion for Tracleer Claims

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DDMAC warns Actelion that a flash card for its Tracleer contains unsubstantiated superiority claims and omits very important risk ...

FDA Revokes Cephalosporin Prohibition

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Federal Register Final rule: FDA revokes its order prohibiting extralabel use of cephalosporin antimicrobial drugs in food-produci...

Guidance on Substances Prohibited in Animal Feed

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FDA releases a draft guidance for renderers on substances prohibited from use in animal food or feed in order to prevent the sprea...

Info on Med Guide Requirements Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on prescription drug product labeling and medication guide...

Comments Sought on TV Drug Ad Toll-Free Numbers

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Federal Register Notice: FDA seeks comments on a study examining consumer comprehension of a toll-free number included in DTC pres...

Workshop on Sex Differences in Cardio Device Trials

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Federal Register Notice: FDA and AdvaMed co-sponsor a public workshop 12/9 on sex differences in cardiovascular device trials.

FTC Proposes Endorsement Guide Changes

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The Federal Trade Commission will take public comment on proposed changes to its guides for advertising that uses endorsements and...

FDA Delays Approval of J&J Antibiotic

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An FDA complete response letter rejects J&Js NDA for ceftobiprole until additional audit work of clinical investigator sites is pr...

Merck Updates Vaqta Supply Availability

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Merck reports that Vaqta vaccine for pediatric/adolescent use will be available for order beginning 12/1/08.