Pharma News Intelligence February 12, 2020
Ana Mulero

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The agency held a public workshop last December to inform the development of the fourth draft guidance to come out under the patient-focused drug development program of FDA’s Center for Drug Evaluation and Research.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...

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