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 ...
CDRH director Jeff Shuren says the Center has seen its work load grow substantially under the Covid-19 pandemic, and its having a negative impact on m...
FDA adds product disposal content to a question-and-answer appendix in its guidance titled Conduct of Clinical Trials of Medical Products During Covid...