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Guide on Device Security Quality Considerations

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerat...

Comments Reopened on AI in Drug Manufacturing

[ Price : $8.95]

Federal Register notice: FDA reopens the comment period on a 3/1 notice entitled Discussion Paper: Artificial Intelligence in Drug...

Peace Wellness Marketing Tissue Products: FDA

[ Price : $8.95]

FDA says Phoenix-AZ-based Peace Wellness Center is marketing stem cell products and exosomes that require approval through a BLA o...

Philips Hid Breathing Machine Complaints: Report

[ Price : $8.95]

A ProPublica/Pittsburgh Post-Gazette in-depth report says Philips Respironics kept from FDA adverse event reports describing serio...

Nephron Pharma Hit Again with FDA-483

[ Price : $8.95]

A just-released Form FDA-483 shows that four months after a 10/2022 Warning Letter, the agency cited the firm again after an inspe...

Device QS Cybersecurity Guidance

[ Price : $8.95]

FDA publishes a guidance on Quality System considerations and the content of premarket submissions relating to medical device cybe...

FDA Rejects Anti-Sweating Gel

[ Price : $8.95]

FDA issues Botanix Pharmaceuticals a complete response letter on its NDA for sofpironium bromide gel, indicated for treating prima...

Guide on Animal Antimicrobials Duration of Use

[ Price : $8.95]

FDA posts a draft guidance with recommendations on how animal drug sponsors may voluntarily establish a defined duration of use fo...

FDA Pushing EG, DEG Testing

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Reuters says its analysis of FDA regulatory actions shows an agency crackdown on companies that fail to sufficiently test cough sy...

Guilty Plea in Adulterated HIV Meds Case

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The Justice Department says a Florida man pleaded guilty to one count of conspiracy to introduce adulterated and misbranded HIV dr...