Analysts and investors interviewed by Reuters see a short-term positive reaction to the departure of Marty Makary, but caution that a prolonged leader...
FDA releases a draft guidance detailing how the agency will evaluate the benefits and risks of new opioid analgesic drugs, emphasizing that approval d...
A King & Spalding legal analysis examines FDAs newly announced pilot program for one-day inspectional assessments, suggesting it may signal a long-ter...
FDA warns Indias Ashirwad Hospital Center and clinical investigator Mukesh Chandre about failing to obtain informed consent for a bioequivalence study...
FDA warns Israels Naveh Pharma and Atlanta, GA-based Bigdam about selling unapproved new drugs that are adulterated by CGMP violations.
FDA commissioner Marty Makary hands in his resignation after a week of mounting speculation that the Trump Administration was preparing to remove him....
Stakeholders ask FDA to clarify its draft guidance on responses to an FDA-483.
An FDA Federal Register notice requests information from drug developers and academic investigators to support a pilot project focused on novel biomar...
