Zdrowie i gospodarka · 14/11/2019

FDA Announces Public Workshop to Discuss Incorporating Clinical Outcome Assessments into Drug Development Endpoints

The FDA is hosting a public workshop to gather input on incorporating clinical outcome assessments into drug development endpoints, as required by the 21st Century Cures Act and as part of its commitments under the Prescription Drug User Fee Amendments (PDUFA VI). The workshop aims to inform the development of patient-focused drug development guidance.