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A Greater Power: US FDA May Become More Insistent on Timing of Accelerated Approval Confirmatory Trials, Pink Sheet

Wednesday, January 25, 2023

Partner Jacqueline Berman is featured in a Pink Sheet article noting how drug and biologic product sponsors should anticipate that US Food and Drug Administration (FDA) review divisions will become more insistent in 2023—though perhaps not guaranteed—about the need for confirmatory trials to be underway when a product receives accelerated approval.

There is “room for the agency to exercise its discretion. Like many things in the clinical development process, it will likely be part of a discussion with [the] FDA,” said Jacqueline.

“And so, like any discussion with an agency, sponsors should be thinking about what might serve their product and what might serve their patient population best when going into these discussions.”

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