Inspection Questions Delay CBER’s Embrace Of Real-Time Oncology Review

 
• By Derrick Gingery

The oncology branch of the US FDA’s biologics center does not believe RTOR would speed application reviews.

A scientist in sterile coverall gown pipetting medium or reagents for cell culture experiment in biological safety cabinet.
The complex biologic manufacturing process could limit the applicability of real-time review. • Source: Shutterstock

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