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US FDA Could Have Avoided Clinical Data Waste With Authority Over All COVID-19 Trials

 
• By Derrick Gingery

Even if the agency had the legal power, it likely did not have the resources to oversee all clinical trials, rather than only those that qualified under the IND regulations, but the extra oversight could have increased coordination and ensured more data was fit for regulatory purposes.

code of federal regulations
Increased FDA clinical trial oversight could have increased the amount of regulatory-grade data during the COVID-19 pandemic. • Source: Shutterstock

BOSTON – Many more COVID-19 pandemic clinical trials could have contributed to regulatory decisions if they were not outside the US Food and Drug Administration’s regulatory reach.

Hundreds of studies, especially early in the pandemic, were exempt from FDA investigational new drug product regulations. Kevin Bugin, deputy...

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