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OMB Approves 4 Information Collections

[ Price : $8.95]

Federal Register notice: FDA posts a list of information collections that have been approved by the Office of Management and Budge...

CGMP Violations at BBC Group

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FDA warns Chinas BBC Group about CGMP violations in its production of finished pharmaceuticals, along with unapproved new drug and...

Inspection Finds CGMP Issue at Sanit Technologies

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FDA warns Sanit Technologies about CGMP violations in its production of finished drugs.

Stem Cell Therapy Firm Marketing Unapproved Cellular Products

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FDA cautions Stem Cell Therapy of Las Vegas that it is marketing unapproved cellular products and exosomes.

FDA Clears Surround Medical Systems Dental Imaging

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FDA clears a Surround Medical Systems 510(k) for its Portray dental imaging system, a 2D diagnostic tool that allows 3D tomosynthe...

SpinTech MRI Software Cleared by FDA

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FDA clears a SpinTech 510(k) for its Stage magnetic resonance imaging software.

Metastasis-Free Survival Endpoint Guide

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Federal Register notice: FDA makes available a final guidance entitled Nonmetastatic Castration-Resistant Prostate Cancer: Conside...

Guide on Near Infrared Analytical Procedures

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Federal Register notice: FDA makes available a final guidance entitled Development and Submission of Near Infrared Analytical Proc...

Axsome Warns on NDA Review Delay

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Axsome Therapeutics warns investors of a potential review delay for its NDA for AXS-05 (dextromethorphan bupropion) for treating m...

White House Shoots Down Rumored FDA Head Prospect

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The White House denies that a rumored candidate for FDA commissioner, former Obama White House advisor Ezekiel J. Emanuel, is in t...