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.
FDA publishes draft guidances on developing non-opioid analgesics for chronic pain and facilitating a benefit/risk analysis for opioid analgesics.
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.
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 leadership vacuum could further damage the agency.
