Sens. Mullins and Booker introduce bipartisan legislation to permit electronic transmission of drug prescribing information to healthcare professional...
FDA approves a Viatris and Ocuphire Pharma NDA for Ryzumvi (phentolamine ophthalmic solution) 0.75% for treating pharmacologically-induced mydriasis (...
FDA clears a Boston Scientific 510(k) for its AVVIGO+ Multi-Modality Guidance System, which the company describes as a streamlined platform that enhan...
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...
