FDA tests its capability to receive annotated electrocardiogram waveform data in electronic format under the Health Level Seven (HL7) Annotated ECG Wa...
Former FDA Office of Compliance and Biologics Quality deputy director Mark I. Schwartz criticizes FDA for its slow response to the need for alternativ...
The Justice Department files a civil complaint to stop AMARC Enterprises from distributing unapproved and misbranded drugs and adulterated animal drug...
FDA issues a safety alert to warn patients and health care providers about patient injuries from wearing face masks that contain metal parts and coati...
FDA details the launch of a new pilot program to provide a pathway for novel drug development tools to be used in regulatory applications for new medi...
Federal Register notice: FDA makes available a final guidance entitled Requesting FDA Feedback on Combination Products.
FDA clears an Ensemble Orthopedics 510(k) for its Ensemble CMC Implant for treating patients with early-stage osteoarthritis of the carpometacarpal jo...
FDA approves labeling changes on Mercks Januvia (sitagliptin), Janumet (sitagliptin and metformin hydrochloride), and Janumet XR (sitagliptin and metf...