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Federal Register notice: FDA makes available a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerat...[ Price : $8.95]
Federal Register notice: FDA reopens the comment period on a 3/1 notice entitled Discussion Paper: Artificial Intelligence in Drug...[ 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...[ Price : $8.95]
A ProPublica/Pittsburgh Post-Gazette in-depth report says Philips Respironics kept from FDA adverse event reports describing serio...[ 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...[ Price : $8.95]
FDA publishes a guidance on Quality System considerations and the content of premarket submissions relating to medical device cybe...[ Price : $8.95]
FDA issues Botanix Pharmaceuticals a complete response letter on its NDA for sofpironium bromide gel, indicated for treating prima...[ Price : $8.95]
FDA posts a draft guidance with recommendations on how animal drug sponsors may voluntarily establish a defined duration of use fo...