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Bacterial Meningitis Vaccine Age Range Expanded

[ Price : $8.95]

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

[ Price : $8.95]

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...

FDA OKs Generic Ellence

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FDA approves an Abraxis Pharmaceutical Products ANDA for a generic copy of Pfizers Ellence.

SenoRx System with Ultrasound Cleared

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FDA clears a SenoRx 510(k) for the SenoSonix System, an integrated version of the firms EnCor breast biopsy system and an ultrasou...

FDA Litigators Shift Focus from Personal Accountability

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Consulting editor John Scharmann questions an apparent FDA trend away from applying the Park doctrines strict personal accountabil...

FDA Changing Vaccine Processing Regs

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FDA publishes a direct final rule loosening requirements for processing live vaccines.