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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

The IRA And US FDA: How Will Agency View Any Drug Development Changes?

US biopharma companies are warning of significant changes in drug development priorities as they prepare for the implementation of new Medicare pricing measures enacted in 2022. Those changes will have ripple effects on the FDA, which may spark some responses.

Research & Development Legislation

US FDA’s Biggest Post-COVID Challenge May Be Helped By Small Inspections Tweak In FDORA

The omnibus spending bill included dozens of reform provisions related to the US FDA. One seemingly minor change to FDA’s inspection authorities could end up being a big help to the challenges ahead in catching up after the COVID-19 pandemic.

Manufacturing Legislation

Accelerated Approval Price Caps: Policy Has High Profile Support – But Can It Be Done?

US Medicare Payment Advisory Commission likely to recommend that drugs granted Accelerated Approval be subject to some form of price cap when confirmatory clinical data is lacking. The idea has a lot of supporters, but even they seem a bit unclear about how it could actually work.

Pricing Debate Review Pathway

US FDA’s Long Wait For Diagnostics Reform Legislation Continues

FDA is hoping Congress might take up proposed legislation governing the regulation of diagnostic tests produced in laboratories in 2023. That will make it a full decade of stalemate since FDA outlined a framework to address the new reality of personalized medicine.

Personalized Medicine Legislation

What Exactly Is A ‘Small Biotech’? US Medicare Agency Will Try To Spell It Out

CMS’s new price negotiation authority has an exemption for ‘small biotech’ companies. The agency’s implementation plan suggests that will be a tricky concept to define.

Reimbursement Medicare

Closing The Books On Aduhelm: Congressional Report Leaves US FDA To Move Forward

A Congressional report on the US FDA approval of Biogen/Eisai’s Aduhelm generated another round of negative headlines for the agency – and rubbed salt in the wounds of a commercial disaster for the sponsors. But it probably could not have turned out better for FDA and the drug review climate overall.

Drug Review Drug Approval Standards
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