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IMDRF Draft Cybersecurity Guidance

[ Price : $8.95]

The International Medical Device Regulators Forum publishes a draft medical device cybersecurity guidance.

NIH Funds Biomed Tech Hubs

[ Price : $8.95]

The National Institutes of Health awards $29 million to fund five additional Research Evaluation and Commercialization Hubs to spe...

Merck Seeks to Expand Dificid Labeled Use

[ Price : $8.95]

FDA accepts for priority review a Merck NDA for Dificid (fidaxomicin) for oral suspension, and a supplemental NDA for a new indica...

Puma Biotech Labeling Supplement for Nerlynx

[ Price : $8.95]

FDA approves a Puma Biotechnology labeling supplement for Nerlynx (neratinib) for the extended adjuvant treatment of HER2-positive...

Ex-FDA Head Califf Moves Full-time at Alphabet

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Former FDA commissioner Robert Califf accepts a full-time role at Alphabet Company as the head of medical strategy and policy for ...

Luminex 510(k) Cleared for Aries MRSA Assay

[ Price : $8.95]

FDA clears a Luminex 510(k) for the Aries MRSA Assay, a real-time, polymerase chain reaction-based, in vitro diagnostic test for d...

Shanghai Institute Refused FDA Inspection

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FDA warns Chinas Shanghai Institute of Pharmaceutical Industry that the agency may withhold approval of ANDAs or supplements listi...

Edits Suggested for BEST Taxonomy

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Four pharmaceutical stakeholders suggest edits to the FDA BEST glossary of biomarker, endpoints, and other tools.

Complete Response Letter for AZ COPD Drug

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AstraZeneca says it will work closely with FDA on next steps after receiving a complete response letter for its PT010 experimental...

24 Drugs not Withdrawn Due to Safety/Efficacy: FDA

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Federal Register notice: FDA determines that 24 drug products were not withdrawn due to safety or effectiveness reasons.