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Federal Register Final order: FDA classifies a gastrointestinal assay into Class 2.[ Price : $8.95]
FDA accepts for priority review an Acadia Pharmaceuticals NDA for Nuplazid (pimavanserin) for treating psychosis associated with P...[ 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...[ Price : $8.95]
Teva petitions FDA asking it not to approve any ANDAs that reference Treanda (bendamustine hydrochloride) until its orphan exclusi...[ Price : $8.95]
FDA posts a guidance on Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment that provides reco...[ Price : $8.95]
CDRH posts a draft guidance on Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medic...[ Price : $8.95]
FDA posts a draft guidance on Progesterone Bioequivalence Recommendations that provides the current agency thinking on studies tha...[ Price : $8.95]
Quest Medical recalls its Myocardial Protection System Delivery Sets due to the potential to have intermittent seal failure during...