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 headlines showed a robust tally of new drug approvals from the US FDA in 2025, but cracks are beginning to show that could turn into fissures in the year ahead.
The grilling of several leading US insurance executives by two House committees suggested one benefit from the Most Favored Nation pricing deals is that for one day, someone else was on the hot seat.
No sponsors have been accepted into the Split Real-Time Application Review pilot program and its extension beyond 2027 appears unlikely.
FDA officials want to see more use of alternative approaches to preclinical pediatric safety analyses, but for now are ready to be patient rather than issue mandates.
Pink Sheet editors and special guest Michael McCaughan discuss the legacy of long-time Oncology Center of Excellence Director Richard Pazdur, who retired from the FDA in December.
Richard Pazdur joined the US FDA almost a decade after the accelerated approval pathway was invented, but no one played a larger role in shaping its use in the 2020s.