Three Morgan Lewis attorneys say companies regulated by FDA should prepare for increased scrutiny due to near-real-time data being available in the agency’s new Adverse Event Monitoring System.
A CDER Office of Prescription Drug Promotion Notice of Violation cites a misleading BeOne Medicine TV spot for its leukemia drug Brukinsa.
Three Morgan Lewis attorneys say companies regulated by FDA should prepare for increased scrutiny due to near-real-time data being available in the agency’s new Adverse Event Monitoring System.
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 leadership vacuum could further damage the agency.
FDA releases a draft guidance detailing how the agency will evaluate the benefits and risks of new opioid analgesic drugs, emphasizing that approval decisions will consider not only patient outcomes but also broader public health effects such as misuse, abuse, overdose, and opioid use disorder.
