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Memo To US FDA: ‘Too Fast!’ Plus ‘Too Slow!’ Does Not Mean ‘Just Right!’

 
• By Michael McCaughan

There is an old adage that FDA only has two speeds: too fast and too slow. Recent pushback on neurology reviews and Covid vaccines show that paradox – but also the flaw of treating contradictory criticism as a sign that everything is actually fine.

US FDA has much more sophisticated decisions to make. • Source: Alamy

US Food & Drug Administration Center for Drug Evaluation & Research Director Patrizia Cavazzoni’s first appearance as a Congressional witness in her new role as the top drug regulator at FDA must have felt disconcerting.

She appeared before the House Energy & Commerce/Health Subcommittee on 29 July after weeks of headlines about FDA’s decision to...

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US FDA Independence Questioned At CDC Oversight Hearing

 
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A Senate committee is investigating leadership changes at the US Centers for Disease Control and Prevention. While the primary focus is vaccine policy, the first hearing suggested the probe could raise questions about FDA independence.

Evita’s Mifepristone Approval Reignites Abortion Pill Controversy

 
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Pink Sheet Podcast: Government Shutdown’s Impact On US FDA, Pfizer Inks Drug Pricing Deal

 
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Pink Sheet reporter and editors discuss the issues that could arise for the FDA as it navigates the government shutdown, as well as the aftershocks of Pfizer’s drug pricing deal with the White House.