Michael McCaughan

Michael McCaughan

Founder, Prevision Policy

Washington, DC

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

Insurance CEOs In The Hot Seat: House Hearings Emphasize Rx Access, Not Prices

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.

After Push To Expand ‘Real-Time’ Application Review Beyond Oncology, STAR Gets No Takers

No sponsors have been accepted into the Split Real-Time Application Review pilot program and its extension beyond 2027 appears unlikely.

US FDA Eager For Sponsors To Use New Preclinical Methods In Pediatrics, But No Mandates Yet

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 Podcast: Oncology Stalwart Richard Pazdur Leaves US FDA

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.

Modernizing Accelerated Approval: One Of Pazdur’s Biggest Legacies

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.

US FDA’s Richard Pazdur: Appreciating An Extraordinary Career

Richard Pazdur is leaving the US FDA amid a time of unprecedented turmoil and uncertainty, but that should not obscure the transformative impact he had on oncology in the US and around the world.