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US FDA Integrated Assessment Roll-Out Expanding By End Of 2021

 
• By Derrick Gingery

All NMEs and original BLAs are expected to adhere to the team-based review approach by the end of the year, with expansion to other application types later.

Stacks of paper
The integrated review is intended to streamline FDA product approval packages, which can number in the hundreds of pages. • Source: Alamy

Sponsors should notice more widespread use of the integrated assessment concept within US Food and Drug Administration review divisions later this year, and potentially the growing pains that may come with it.

The integrated assessment is intended to encourage more collaboration among FDA assessors. The process includes the controversial combined review where...

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