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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.
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Latest From Michael McCaughan

New Faces In US FDA Review Division Leadership

Final phase overhaul of FDA's new drug review groups includes half-a-dozen first-time division directors. Most have long experience at the agency – but not all with the drugs they will now oversee.

Drug Review FDA

Off-Label Promoter In Chief: President Trump Pushes COVID-19 Therapy

If the President says over and over again that a drug is approved, does that make it so?

Coronavirus COVID-19 Leadership

Biosimilar Competition: Still More Focus On FDA Than FTC

A joint meeting of the US FDA and the FTC on biosimilar competition may have delivered a symbolic message about the need for a ‘level playing field’ in the biologics market – but it did not deliver much in the way of an actionable agenda for antitrust regulators.

Biosimilars Enforcement

‘Big Shoes To Fill’: US FDA Commissioner Hahn’s Baptism By Fire

Every new FDA commissioner faces a challenge earning credibility with Congress and the public, but in the context of COVID-19, Stephen Hahn has a double challenge of a public health crisis – and the ongoing prominence of his predecessor at the agency.

FDA Leadership

‘Big Shoes To Fill’: US FDA Commissioner Hahn’s Baptism By Fire

Every new FDA commissioner faces a challenge earning credibility with Congress and the public, but in the context of COVID-19, Stephen Hahn has a double challenge of a public health crisis – and the ongoing prominence of his predecessor at the agency.

FDA Leadership

‘Big Shoes To Fill’: US FDA Commissioner Hahn’s Baptism By Fire

Every new FDA commissioner faces a challenge earning credibility with Congress and the public, but in the context of COVID-19, Stephen Hahn has a double challenge of a public health crisis – and the ongoing prominence of his predecessor at the agency.

FDA Leadership
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