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 a Federal Register notice. The agency added that the meetings “have given FDA a deeper appreciation for the expertise that patients and caregivers can bring to the process and the value of incorporating their voice.” ...