Pharma News Intelligence February 12, 2020
With the forthcoming FDA guidance on patient-focused drug development, BIO and PhRMA argued for clarity on what patient experience data informs FDA
Biotechnology and pharmaceutical stakeholders largely supported guidance from the FDA on patient-focused drug development, but some sought some clarification about FDA decision-making.
The agency held a public workshop last December to inform the development of the fourth draft guidance to come out under the patient-focused drug development program of FDA’s Center for Drug Evaluation and Research. It engaged drug developers and industry groups, among others.
Holding the public workshop completes a portion of FDA’s commitments under the latest reauthorization of the Prescription Drug User Fee Amendments (PDUFA VI). The agency issued guidance documents outlining consideration factors for...