Federal Register notice: FDA announces that Y-mAbs Therapeutics was awarded a priority review voucher related to the approval of Danyelza (naxitamab-g...
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 announces the revocations of Emergency Use Authorizations issued to manufacturers of certain protective barrier enclosure...
CDERs Office of Prescription Drug Promotion seeks approval to expanding on previous direct-to-consumer advertising research involving celebrities and ...