Is The US FDA At A Tipping Point?

Wall Street is worried that a cluster of recent negative regulatory events means tougher reviews going forward. That concern is probably overdone, but a year into the COVID pandemic is a good time to take stock of how FDA is doing.

FDA changing climate
What will be the climate at the US FDA going forward? • Source: photo illustration

It is a testament to how smooth and predictable the US regulatory climate has been for the past few years that a recent spate of negative regulatory updates prompted such a strong reaction among biotech investors.

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