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FDA posts a draft guidance with recommendations on how animal drug sponsors may voluntarily establish a defined duration of use for certain approved m...
Reuters says its analysis of FDA regulatory actions shows an agency crackdown on companies that fail to sufficiently test cough syrups and other produ...
The Justice Department says a Florida man pleaded guilty to one count of conspiracy to introduce adulterated and misbranded HIV drugs into interstate ...
