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Comments Re-opened on Surgical Procedure

[ Price : $8.95]

Federal Register Notice: FDA reopens the comment period on a draft guidance: Same Surgical Procedure Exception: Questions and Answ...

Guidance on Progesterone Bioequivalence for ANDAs

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FDA posts a draft guidance on Progesterone Bioequivalence Recommendations that provides the current agency thinking on studies tha...

Quest Recalls Myocardial Protection System Delivery Sets

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Quest Medical recalls its Myocardial Protection System Delivery Sets due to the potential to have intermittent seal failure during...

Pharmacy Group Creates Biosimilars Intelligence Consortium

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The Academy of Managed Care Pharmacy announces the formation of the Biologics & Biosimilars Collective Intelligence Consortium a ...

FDA Stays Part of Guidance on INDs

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FDA says it is staying part of its final guidance on Investigational New Drug ApplicationsDetermining Whether Human Research Studi...

Guidance on Liposome Drug Products

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Federal Register Notice: FDA releases a draft guidance: Liposome Drug Products: CMC; Human Pharmacokinetics and Bioavailability; a...

510(k) Devices Take 94% of Post-market Surveillance Studies: GAO

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A Government Accountability Office analysis of FDA-ordered postmarket surveillance studies between 3/2008 and 2/2015 finds that 94...

Comments Re-opened on Adipose Tissue Guidance

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Federal Register Notice: FDA reopens the comment period on a draft guidance: Human Cells, Tissues, and Cellular and Tissue-Based P...

CDRH Draft Guidance on Device Electromagnetic Compatibility

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CDRH posts a draft guidance on Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medic...

Lipocine NDA Filed for Testosterone Product

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FDA accepts for filing a Lipocine NDA for LPCN 1021, an oral product candidate for testosterone replacement therapy in adult males...