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
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.
The US FDA is expected to refine warnings recently added to CAR-T cell therapies about the risk of secondary malignancies after reassuring new data, which is a positive sign for the future of the therapies in autoimmune disorders.
HHS Secretary Robert F. Kennedy Jr. is nostalgic for the 1960s. Will that include pushing the agency back to the pre-user-fee-era model of defining success based on blocking unsafe drugs, rather than accelerating access to effective ones?
The US FDA has navigated one round of layoff notices, but more cuts could be coming. Here are three potential scenarios.
With timing that is purely coincidental, but supremely ironic, the US FDA approved two new vaccines on 14 February, the second day of HHS Secretary Robert F. Kennedy Jr.’s tenure on the job.