Federal Register notice: FDA makes available a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of ...
Federal Register notice: FDA reopens the comment period on a 3/1 notice entitled Discussion Paper: Artificial Intelligence in Drug Manufacturing, Requ...
FDA says Phoenix-AZ-based Peace Wellness Center is marketing stem cell products and exosomes that require approval through a BLA or IND.
A ProPublica/Pittsburgh Post-Gazette in-depth report says Philips Respironics kept from FDA adverse event reports describing serious issues with its C...
A just-released Form FDA-483 shows that four months after a 10/2022 Warning Letter, the agency cited the firm again after an inspection documented sig...
FDA publishes a guidance on Quality System considerations and the content of premarket submissions relating to medical device cybersecurity.
FDA issues Botanix Pharmaceuticals a complete response letter on its NDA for sofpironium bromide gel, indicated for treating primary axillary hyperhid...
FDA posts a draft guidance with recommendations on how animal drug sponsors may voluntarily establish a defined duration of use for certain approved m...
