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Ortho Vitros HIV Test Approved

[ Price : $8.95]

FDA approves Ortho Clinical Diagnostics Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator for use on Orthos V...

Guide on Developing Hypertension Combo Drugs

[ Price : $8.95]

FDA releases a guidance on Hypertension: Developing Fixed-Combination Drug Products for Treatment.

Info Collection Revision on Tropical Disease Vouchers

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection revision for Tropical Disease Priority Review Vouchers.

Clinical Trial Meta-Analysis Guidance Out

[ Price : $8.95]

FDA issues a draft guidance outlining factors it will consider when evaluating the strength of evidence provided by drug safety me...

Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company Vital Rx.

Dova Pharma sNDA for Doptelet in ITP

[ Price : $8.95]

FDA accepts a Dova Pharmaceuticals supplemental NDA for Doptelet (avatrombopag) for treating chronic immune thrombocytopenia in pa...

Info Collection Extension on Expanded Access Guide

[ Price : $8.95]

Federal Register notice. FDA seeks comments on an information collection extension for its Guidance for Industry on Individual Pat...

Serious Deficiencies at Atlantic Pharmacy and Compounding

[ Price : $8.95]

FDA cautions Atlantic Pharmacy and Compounding about insanitary conditions in its production of drug products.

Use of Voluntary Consensus Standards Guidance Explained

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A CDRH Webinar explains provisions in a recent guidance on the appropriate use of voluntary consensus standards in premarket submi...

Sandoz Scraps Rituxan Biosimilar Submission

[ Price : $8.95]

Sandoz decides not to pursue FDA approval for its proposed biosimilar of rituximab (Genentechs Rituxan), indicated for treating so...