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GAO Finds Continuing FDA Dissent on TMJ Implants

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A GAO report finds continuing internal CDRH disagreement with FDAs 2001 approval of a device made by TMJ Implants Inc., now fighti...

FDA Clears bioMrieuxs Sepsis Assay

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FDA clears a bioMrieux 510(k) for the Vidas Brahms PCT test for assessing a patients risk for developing severe sepsis.

FDA Proposes Change on Live Vaccine Processing Regs

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Federal Register Proposed rule: FDA proposes to amend the biologics regulations by providing options for live vaccine processing r...

OMB OKs Special Protocol Assessment Info

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Federal Register Notice: The Office of Management and Budget approves a collection of information on a guidance on special protoco...

Bacterial Meningitis Vaccine Age Range Expanded

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FDA approves an expanded indication for Sanofi Pasteurs Menactra, revising the age range down to include those between two and 10 ...

Panel to Discuss Astellas Pharma and Solvay NDAs

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Federal Register Notice: FDAs Cardiovascular and Renal Drugs Advisory Committee will meet 12/11-12 to discuss an Astellas Pharma N...

Panel Mulls Prestwick NDA for Chorea in Huntingtons

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Federal Register Notice: FDAs Peripheral and Central Nervous System Drugs Advisory Committee will meet 12/6 to discuss Prestwick P...

Sole Drug Manufacturers Must Notify Before Discontinuing

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Federal Register Final rule: FDA amends it postmarketing reporting requirements to require an applicant who is the sole manufactur...

CBER Cites CSL Behring DTC Materials for Mononine

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CBER cites a CSL Behring LLC direct-to-consumer promotional brochure and Web site (www.HemophiliaB.com) for Mononine (coagulation ...

FDA Requires Updated Hearing Loss Labeling on ED Drugs

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FDA says it has approved labeling changes to erectile dysfunction drugs Viagra, Cialis, and Levitra to display more prominently an...