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US FDA’s Biggest Post-COVID Challenge May Be Helped By Small Inspections Tweak In FDORA

 
• By Michael McCaughan

The omnibus spending bill included dozens of reform provisions related to the US FDA. One seemingly minor change to FDA’s inspection authorities could end up being a big help to the challenges ahead in catching up after the COVID-19 pandemic.

document review
FDORA allowed remote records requests to count as FDA inspections. • Source: Shutterstock

It is probably foolish to try to claim that any one provision of the US Food and Drug Administration Omnibus Reform Act enacted at the end of 2022 is the most important of all the changes.

After all, there are dozens of provisions addressing different elements of the FDA’s authorities over drug and device regulation

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