Michael McCaughan is a founding member of Prevision Policy LLC, a leading provider of regulatory and reimbursement policy analysis for the biopharma industry. He was previously the Editor-In-Chief of The Pink Sheet and remains a contributor to the publication.
Latest from Michael McCaughan
The FDA generic drugs team’s first public workshop of the second Trump Administration ended with a request that industry amplify the value it finds from public engagement.
Republican congressional staffers could bring a wealth of experience and strong contacts with key legislators to the FDA ahead of the next user fee reauthorization process. But will Health and Human Services Department leadership interfere?
US CMS Administrator nominee Mehmet Oz promises to inspire the agency he is set to lead and seems likely to succeed compared to other Trump Administration nominees.
The FDA generic drugs team’s first public workshop of the second Trump Administration ended with a request that industry amplify the value it finds from public engagement.
US FDA Commissioner nominee Martin Makary appears set for an easy confirmation after Senate Democrats declined to press him on past inflammatory statements about the agency.
The explosion in pharmacy compounding as a source of GLP-1 weight loss medications has put the FDA in a tough spot to defend its drug shortage policies, but it is not the first time that compounding has posed a potentially significant threat to agency authorities.