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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

US FDA Has Done Over 200 ‘Mission Critical’ Inspections During COVID

For now, agency appears to be in early stages of testing alternative inspection models beyond the flexibility it has been applying throughout the pandemic.

Manufacturing Coronavirus COVID-19

COVID-19 And The Drug Pricing Debate: Disruption Helps Industry More Than R&D

CEO accountability hearing in US House shows that the COVID-19 outbreak is helping to blunt attacks on the drug industry over its pricing – just not entirely in the way the industry hoped.

Pricing Debate Politics

US FDA Digital Health Center Will Help Prioritize Activities And Identify Needs

Significant resources will likely depend on the next user fee agreement, but the launch of a Digital Health Center of Excellence will help the US FDA better prioritize ongoing work in the emerging field and help to identify needs for new talent, Deputy Commissioner Abernethy says.

User Fees Digital Health

US FDA Credibility: Surprisingly Strong, Despite Everything

A Senate Health Committee update hearing on the COVID-19 federal response was noteworthy primarily for demonstrating that FDA Commissioner Stephen Hahn appears to have salvaged the agency’s position as a voice of credibility with a key political constituency – at least for now.

FDA Leadership

US FDA’s First Amendment Defense

Before taking over the US health department, Alex Azar helped bring landmark litigation challenging the scope of FDA’s regulatory authority under the First Amendment. Now his tenure is ending with a First Amendment defense of the agency.

Advertising, Marketing & Sales Legal Issues

‘March In’ Plan Unveiled By Democratic Think Tank: A Battle Biopharma Would Welcome?

In sign of how much has changed in four years, industry might be better off if Biden takes CAP’s advice and launches ‘march-in’ actions to address pricing of COVID products.

Pricing Debate Intellectual Property
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