PDUFA VI: Innovative Trial Design Proposal Includes Modeling, Simulation
This article was originally published in The Pink Sheet Daily
Both ideas also will require more FDA expertise, agency tells industry.
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Meeting requests from sponsors that focus on safety prediction will also be prioritized.
Modeling can better inform candidate and dose selection, and support novel endpoints, labeling and postmarketing safety, even though it means stepping off the beaten path for drug development, participants say at US FDA's inaugural workshop on model-informed drug development under PDUFA VI.
The entire PDUFDA VI reauthorization process likely is more than a year from completion, but agreeing on a draft commitment letter is a major milestone for FDA and the pharma industry. It will serve as the foundation of the legislative phase expected to begin in early 2017.