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Guidance on Progesterone Gel BE Studies

[ Price : $8.95]

Federal Register Notice: FDA releases a document for industry: Draft Guidance on Progesterone to provide recommendations on bioequ...

Guidance on Electromagnetic Compatibility of Devices

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance: Information to Support a Claim of Electromagnetic Compatibility (EMC) of E...

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

[ Price : $8.95]

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

FDA Breakthrough Status for Giant Cell Tumor Therapy

[ Price : $8.95]

FDA grants Daiichi Sankyo and Plexxikon a breakthrough therapy designation for their investigational oral CSF-1R inhibitor pexidar...

OMB OKs Info on Ad Exposure

[ Price : $8.95]

Federal Register Notice: The Office of Management and Budget approves a collection of information on the impact of ad exposure fre...

OMB OKs Info on Generic Drug Pill Characteristics

[ Price : $8.95]

Federal Register Notice: The Office of Management and Budget approves a collection of information on a survey on the physical char...