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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 Tortoise, The Hare, And COVID Vaccines: The Hare Wins

Merck wasn’t as quick to the COVID vaccine race as some others, but it believed that its use of ‘proven platforms’ would win out in the end. Not anymore.

Vaccines Research & Development

Trump’s Legacy Versus ‘March In’ Rights

Biden’s incoming Secretary of Health is a fan of ‘march in’ rights as a cost-containment tool for medicines. Two hold-overs from Trump Presidency may slow him down.

Elections Intellectual Property

Is The Opioid REMS Too Big To Study?

US FDA’s workshop to discuss new ideas to assess the impact of the opioid REMS comes after the industry collaboration behind the REMS has deemed the task essentially impossible.

Safety Post Market Regulation & Studies

Growing Pains For US FDA Oversight Of Opioids: Starting Over On Assessment Of REMS

Whether CME for pain management has the intended impact on prescribing is likely focus of new ‘suite of studies’ intended to assess the opioid REMS program. The challenges for FDA include teasing out the impact of the risk management program amid all the other public health efforts on opioids.

Drug Safety Post Market Regulation & Studies

The US FDA’s Nifty Fifty

FDA has approved over 50 new molecular entities in a year for the second time – a truly remarkable job amid a global pandemic. But will 2021 be a tougher year?

Approvals Coronavirus COVID-19

The Absurd COVID-19 Vaccine Regulatory Race

Donald Trump is no longer the only one who thinks the US FDA is moving too slow on allowing broad access to COVID-19 vaccine candidates. But before the narrative that FDA’s caution cost lives takes root, let’s remember the facts: the key milestone isn’t when an effective vaccine is authorized, but when supplies are sufficient to mount an effective vaccination campaign.

FDA Drug Review
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