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FDA Clears AnthroTronix DANA App for Psych Testing

[ Price : $8.95]

FDA clears an AnthroTronix 510(k) for its computerized cognitive test battery DANA, which is intended to provide clinicians with a...

FDA OKs Clinical Trial in Ebola Patients

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FDA approves a Phase 2 clinical trial protocol from Chimerix to begin clinical trials of brincidofovir in Ebola patients.

FDA Approves Abuse-deterrent Claim on Pfizers Enbeda

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FDA approves new abuse deterrent labeling for Pfizers painkiller Embeda (morphine sulfate and naltrexone hydrochloride) extended-r...

Spectrum Wants Fusilev Approval Date, Exclusivity Extended

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Spectrum asks FDA to extend the approval date and orphan drug expiration date for its Fusilev to account for the delay in launch c...

Advisors Asked About Cosentyx Efficacy, Safety

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FDA medical reviewers tell the Dermatologic and Ophthalmic Drugs Advisory Committee that Novartis data show a favorable benefit-ri...

Comments Sought on Consumer Tobacco Panel

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Federal Register Notice: FDA seeks comments on establishing a probability-based panel of tobacco users.

FDA Sends Collection of Info on Device Tracking to OMB

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Federal Register Notice: FDA submits a proposed collection of information on medical device tracking to the Office of Management a...

FDA Panel Votes to Retain Chantix Boxed Warning

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A joint FDA advisory committee votes to recommend retaining a boxed warning on Pfizers smoking cessation drug Chantix (varenicline...

CDER Revamp Includes Office of Pharmaceutical Quality

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CDER director Janet Woodcock announces a 1/5/15 Center reorganization that includes creation of a super-office Office of Pharmaceu...

High Court Mixed on Changing Federal Circuits Role in Patent Appeals

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The U.S. Supreme Court expresses mixed reactions to whether the Federal Circuit Court of Appeals should continue to be given leewa...