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FDA to Review Sanctura XR NDA

[ Price : $8.95]

FDAs PDUFA target date for reviewing Indevus Pharmaceuticals NDA for Sanctura XR is 8/13/07.

New DoD Anthrax Suit Filed

[ Price : $8.95]

Service members and contractors file suit against the Defense Department and FDA over reinstatement of a mandatory anthrax vaccina...

Drug Safety Board Mulls Antibiotic Adverse Events

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CDERs Drug Safety Oversight Board reviews adverse events reported in patients separately taking fluoroquinolone antibiotics and dr...

Grassley Ramps Up Ketek Probe

[ Price : $8.95]

On the eve of an advisory committee review, outgoing Senate Finance Committee chairman Chuck Grassley sends FDA a 53-page complain...

FDA Sends Info on Labeling in e-Format to OMB

[ Price : $8.95]

Federal Register Notice: FDA sends a proposed collection of information on the requirements for submission of labeling for human p...

FDA Advisors Vote for Antidepressant Label Changes

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FDAs Psychopharmacologic Drugs Advisory Committee votes in favor of modifying antidepressant black box wording and MedGuides to re...

Animal Drug Regs Implement Manufacturing Changes

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Federal Register Final rule: FDA amends its animal drug regulations to implement the manufacturing changes provisions for suppleme...

Postmarket Surveillance Info Sent to OMB

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Federal Register Notice: FDAs proposed collection of information on postmarket surveillance has been submited to the Office of Man...

LA District, SoCRA Plan Workshop on Trial Regs

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Federal Register Notice: FDAs LA District and the Society of Clinical Research Associates plan a public workshop 2/7-8 in San Dieg...

Moderate Growth Seen in Antidepressants

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Decision Resources projects modest sales growth for antidepressants in the next decade because of patent expirations in several le...