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3 New Medication Guides Available

[ Price : $8.95]

FDA announces availability of Medication Guides for Extavia, Sabril, and Penpep.

Tennis Great in GSK Prostate Cancer Screening Program

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Tennis great John McEnroes voice and image are part of a new GlaxoSmithKline campaign to promote revised prostate cancer screening...

FDA OKs J.B. Chemicals Generic Zyrtec

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FDA approves a J.B. Chemicals and Pharmaceuticals ANDA for a generic equivalent of McNeil Consumer healthcares allergy drug Zyrtec...

Public Workshop on Blood Establishment Software

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Federal Register Notice; FDA plans a public workshop 11/4-5 in Rockville, MD on understanding what to include in a 510(k) submissi...

GSK Reports 2 Advair Diskus Lots Stolen

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FDA says it is helping GlaxoSmithKline investigate the theft of two lots of Advair Diskus inhalers from a distribution facility.

Geron IND Trial Hold Deals with Cysts in Animals

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Geron Corp. says FDAs clinical hold on its spinal cord injury IND relates to injury site cysts that developed in tested animals.

FDA Outlines Drug Ingredient Supply Chain Risks

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CDER international compliance branch chief Edwin Rivera-Martinez outlines risks affecting the integrity of pharmaceutical ingredie...

New Safety Issues Reported for Tibotecs Intelence

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FDAs MedWatch program reports new safety issues for Tibotec Therapeutics accelerated-approval HIV drug Intelence, include Stevens-...

FDA Clears Asfora Bullet Cage for Lumbar Surgeries

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FDA clears Sanford Healths Asfora Bullet Cage for use in posterior lumbar interbody fusion surgeries.

Promo Risk Guidance Needs More Device Info: AdvaMed

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AdvaMed raises concerns about the applicability of FDAs draft guidance on risk information in promotional pieces to medical device...