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FDA releases a draft guidance detailing how the agency will evaluate the benefits and risks of new opioid analgesic drugs, emphasizing that approval d...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 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.
