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Allergan Sues to Share Truthful Off-label Information

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Allergan asks a federal court for a ruling permitting it to share truthful information about off-label Botox therapies with doctor...

Appeals Court Supports FDA Anthrax Vaccine OK

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A federal appeals court says FDA properly approved the anthrax vaccine and the Defense Department may administer it to members of ...

FDA Plans Second Transparency Public Meeting

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FDA plans a second public meeting 11/3 to receive comments on how to ensure that information about certain agency activities and d...

FDA Update on Calcium Disodium Versenate Shortage

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FDA says a drug shortage involving Graceway Pharmaceuticals calcium disodium versenate injection 200 mg/mL 5 mL ampules should be ...

Recent Preemption Cases Support Restrictive Approach

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Law school professor Richard Cupp says that recent Supreme Court decisions show a trend toward a conservative and restrictive appr...

Oncologic Panel Meeting Canceled

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Federal Register Notice: FDAs Oncologic Drugs Advisory Committee scheduled 10/6 has been canceled.

FDA, Oncolytics Reach Agreement on SPA for Reolysin

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FDA reaches an agreement with Oncolytics Biotech Inc. under a Special Protocol Assessment for the design of a Phase 3 trial of Reo...

U.S. Government Defends FDA Tobacco Regulation

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The U.S. government says that restrictions in FDAs regulation of tobacco products that are being challenged by tobacco companies i...

Comments Extended on Tobacco Act

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Federal Register Notice: FDA extends the comment period on the implementation of the Family Smoking Prevention and Tobacco Control...

Companies Heeded FDA Link Warning

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Digital marketing research firm comScore says that use of drug company sponsored links dropped significantly after FDA issued 14 W...