Three Morgan Lewis attorneys say companies regulated by FDA should prepare for increased scrutiny due to near-real-time data being available in the ag...
FDA publishes draft guidances on developing non-opioid analgesics for chronic pain and facilitating a benefit/risk analysis for opioid analgesics.
A CDER Office of Prescription Drug Promotion Notice of Violation cites a misleading BeOne Medicine TV spot for its leukemia drug Brukinsa.
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FDA releases a draft guidance detailing how the agency will evaluate the benefits and risks of new opioid analgesic drugs, emphasizing that approval d...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FDA posts a draft guidance outlining recommendations for drugmakers developing local anesthetic products designed to provide prolonged postoperative p...
FDA warns Indias Ashirwad Hospital Center and clinical investigator Mukesh Chandre about failing to obtain informed consent for a bioequivalence study...
