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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

Rx Import Legislation: One Step Forward, Two Steps Back – And Odd Dance Partners

The strange politics of prescription drug importation legislation in the US are on display again, this time in the context of the FDA user fee reauthorization bill. Including the topic in the bill is a ‘big deal’ – but probably makes imports less likely.

Legislation Politics

US COVID Vaccine Authorizations: Too Much – Or Never Enough?

A US FDA advisory committee review of a novel COVID vaccine candidate from Novavax made one thing very clear: The agency is firmly convinced that when it comes to vaccine options, more is better.

Vaccines Regulation

US FDA Commissioner Califf’s Baptism By Fire – Or, At Least, Formula

Robert Califf’s second tenure as FDA commissioner already feels different from the first, thanks to a national shortage of infant formula – and an abundance of questions about what FDA could have done to prevent it.

Leadership FDA

US FDA’s ‘Mature’ Approach To Quality: ‘Encourage More, Punish Less’

Proposed ‘Quality Management Maturity’ rating system would be a way to be more ‘proactive and rewarding’ rather than ‘punitive’ when it comes to oversight of pharmaceutical manufacturing. The initiative is clearly important to the head of FDA’s drug quality office.

Manufacturing Quality

US FDA Accelerated Approval Council Proposed: Codifying A Failure?

There is certainly some logic to directing the US FDA to create a council of top managers to assure that the Accelerated Approval pathway is used consistently. But it sure sounds like exactly what the agency did with Aduhelm.

Leadership Review Pathway

US FDA Leadership Team: Woodcock’s Next Chapter

The announcement of US FDA Deputy Commissioner’s new focus going forward at the agency may not mean what you think it does. The focus shouldn’t be on what Janet Woodcock is not doing – but on the fact that she is staying on at the agency at all.

FDA Leadership
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