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Michael McCaughan

Michael McCaughan has has 25 years of experience providing analysis and insight about the biopharma industry, including 10 years as Editor-In-Chief of The Pink Sheet and The Pink Sheet DAILY. He speaks frequently on regulatory and policy developments affecting the industry.

Latest From Michael McCaughan

Inter-Agency User Fees? US FDA/ARPA-H Relationship Could Get Interesting

The Biden Administration’s signature health research agency ARPA-H is still in the formative stages. Authorizing legislation moving through Congress could set up a very interesting dynamic when it comes to working with the US FDA.

FDA Research & Development

End Of ‘Phase I’: The Case To Re-Name First-In-Human Oncology Trials

US FDA’s push to re-think oncology dosing should begin by renaming the initial human trials to de-emphasize toxicity, a National Cancer Institute official suggests.

Clinical Trials Regulation

Slow Down To Speed Up: US FDA Presses Cases For Dose Optimization

The US FDA is urging drug companies to abandon traditional approaches to oncology dosing even if it means slowing down early studies. The trade-off should be faster development times overall, FDA says – but sponsors still seem very wary.

Clinical Trials Regulation

Bullet Train: US FDA User Fee Bill Is On Fast Track In House

The House Energy & Commerce Committee is moving rapidly to complete work on a bipartisan reauthorization of the US FDA’s user fee programs – and it isn’t waiting for any riders that aren’t ready on time. For now, at least, that means the CURES 2.0 bill will have to find another track.

User Fees Legislation

US FDA Advisory Committees As The Court Of Appeals

The US FDA’s use of its advisory committees continues to shrink. In 2022, the expert panels appear primarily to serve as a last chance for sponsors to prevent (or overturn) an FDA rejection.

Advisory Committees Drug Review

US FDA Reforms In 2022: One Bill – Or Four?

The draft bipartisan user fee reauthorization bill includes more than 40 ride-along provisions to make changes at the US FDA. But there are at least three other bills moving in Congress that also make FDA reforms.

User Fees Legislation
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