Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Statement of Work; Request for Comments

Resumo

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the Statement of Work to assess communication between FDA and sponsors through product quality information requests during application review and to identify best practices and areas of improvement. The independent assessment is part of FDA performance commitments under the recent reauthorization of the Prescription Drug User Fee Act (PDUFA). The independent assessment of FDA and sponsors in communicating through product quality information requests is described in detail in the document entitled "PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027." As part of FDA performance commitments described in this document, the assessment will be conducted by an independent contractor. FDA is providing for public comment on the statement of work before revising as needed and requesting contractor proposals.