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Gastrointestinal Assay into Class 2

[ Price : $8.95]

Federal Register Final order: FDA classifies a gastrointestinal assay into Class 2.

Acadia Pharma Parkinsons Drug Gains Priority Review

[ Price : $8.95]

FDA accepts for priority review an Acadia Pharmaceuticals NDA for Nuplazid (pimavanserin) for treating psychosis associated with P...

Tryton Medical PMA for Side Branch Stent

[ Price : $8.95]

Tryton Medical files the final module of its PMA for the Tryton Side Branch Stent, indicated for treating bifurcated lesions in pa...

Teva Petitions FDA to Block ANDAs for Treanda

[ Price : $8.95]

Teva petitions FDA asking it not to approve any ANDAs that reference Treanda (bendamustine hydrochloride) until its orphan exclusi...

FDA Guidance on Developing HIV Therapies

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FDA posts a guidance on Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment that provides reco...

CDRH Draft Guidance on Device Electromagnetic Compatibility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CDRH posts a draft guidance on Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medic...

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FDA posts a draft guidance on Progesterone Bioequivalence Recommendations that provides the current agency thinking on studies tha...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