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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

Chloroquine ‘Approval’ For COVID-19 And The US FDA’s New Reality

Asking whether FDA’s decision to allow emergency use of two old anti-malarial drugs was ‘political’ misses the point. The issue already was political, and FDA’s action may well be the best way to keep some measure of federal control on supplies of a drug with important other uses.

Coronavirus COVID-19 Leadership

US FDA Commissioner Hahn’s Star Turn: Baptism By Fire Turns Perilous

FDA Commissioner Stephen Hahn was added to the White House's pandemic task force as the outbreak grew, but he remained in a background role. That all changed the morning of 18 March, when President Trump tweeted: “I will be having a news conference today to discuss very important news from the FDA concerning the Chinese Virus!” A day later, Hahn was standing with Trump at the podium for the now-daily press briefings on Covid-19.

Coronavirus COVID-19 FDA

US FDA Commissioner Hahn’s Star Turn: Baptism By Fire Turns Perilous

Stephen Hahn’s low visibility period as the newly installed FDA commissioner comes to an abrupt end. Trump offers generous praise amid COVID-19 response – but how quickly might that change to blame?

Coronavirus COVID-19 Leadership

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
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