5:49 AM
Jun 12, 2018
 |  BC Extra  |  Politics & Policy

FDA launches patient-focused drug development 2.0

FDA Tuesday published the first of four planned guidance documents that aim to move patient-focused drug development from listening sessions to a set of scientifically robust methods that can be integrated into product development.

The guidance documents build on “learnings from the disease-specific PFDD meetings that FDA conducted under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V) as an enhancement of the Agency’s implementation of a more structured approach to benefit-risk assessment,” according to...

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