Novartis, Sanofi and PhRMA push FDA on how to better handle complex trial designs
Several industry stakeholders are asking the FDA to streamline its processes for working with sponsors on complex and innovative designs for clinical trials. The comments seek more clarity on how the FDA decides whether to accept designs, following a workshop on the topic last month.
The FDA first began offering meetings with sponsors on complex designs as part of a pilot program under the Prescription Drug User Fee Act VI and is now reviewing the program’s progress. The agency previously asked companies for feedback on how to improve the program as it becomes permanent.
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