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

Real-Time Release Of CRLs Is US FDA’s Goal, Agency Leaders Affirm

The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.

From ‘Work Harder’ to ‘Phenomenal People’: Makary’s FDA About-Face

In his first 100 days as FDA commissioner, Martin Makary has gone from vocal critic to vocal supporter of the agency’s staff, calling them “phenomenal” and praising their dedication—even as morale remains shaken by recent layoffs and restructuring.

US FDA Commissioner Makary Is Learning To Appreciate His Staff

After three months on the job, FDA Commissioner Martin Makary is sounding much more effusive about the quality of the agency staff. Better late than never?

Organ-On-A-Chip: Upcoming US FDA Guidance Could Help Flesh Out ‘Roadmap’

The FDA is pushing the use of novel alternatives to animal models, but the Government Accountability Office said sponsors need more clarity and hopes an upcoming guidance will help.

US FDA ‘Commissioner’s Voucher’ As Public Relations Tool

NRx Pharma is trying to capitalize on the headlines about a new US FDA hyper-fast review program, illustrating that the lack of details in the FDA’s announcement is an opening for sponsors to try to grab some attention.

US FDA’s Tough Talk On Talc: Regulating In An Echo Chamber

An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.