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.
A King & Spalding legal analysis examines FDA’s newly announced pilot program for one-day inspectional assessments, suggesting it may signal a long-term shift toward faster, AI-assisted oversight of regulated facilities.
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.
A King & Spalding legal analysis examines FDA’s newly announced pilot program for one-day inspectional assessments, suggesting it may signal a long-term shift toward faster, AI-assisted oversight of regulated facilities.
A CDER Office of Prescription Drug Promotion Notice of Violation cites a misleading BeOne Medicine TV spot for its leukemia drug Brukinsa.
FDA releases a draft guidance detailing how the agency will evaluate the benefits and risks of new opioid analgesic drugs, emphasizing that approval decisions will consider not only patient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.
