After years of low-level enforcement by FDA in relation to promotional communications by the pharmaceutical industry, there has been huge change in the agency's approach. Not only have the numbers exploded, but the focus has shifted. What was, and exactly where was the action? What happened? On September 9, 2025, FDA issued a press release - FDA Launches Crackdown on Deceptive Drug Advertising - making the case that the agency was moving into a new era of enforcement. On that same day the...

Last year media reports stated that FDA was going to move away from holding advisory committee meetings to consider the approval of new drugs and consequently there have been no meetings held since that were for that purpose. However, last week FDA posted notice in the Federal Register that it would be holding two half-day meetings of the Oncologic Drugs Advisory Committee (ODAC), both for the purpose of considering approval decisions, to be held on April 30, 2026. A few observations are...

FDA Great Room - Venue for FDA AdComms There has not been a single FDA Advisory Committee meeting held by the agency nor has one been...