📄FDA Seeks Comments on Product Quality Communication Assessment
Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Final Report; Availability; Request for Comments
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled "Product Quality Information Request Communications Assessment: Final Report." This report fulfills a commitment under the recent reauthorization of the Prescription Drug User Fee Act (PDUFA) to assess communication between FDA and applicants through product quality information requests during application review and to identify best practices and areas of improvement. The assessment of FDA and applicants in communicating through product quality information requests was conducted by an independent contractor, as described 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, FDA is publishing the final assessment report and soliciting public comments.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The document outlines the FDA's initiative to assess and improve communication through product quality information requests, impacting pharmaceutical businesses. Compliance with new practices will be required, affecting how companies engage with the FDA during application reviews. The solicitation of public comments further emphasizes the regulatory landscape evolving under the PDUFA framework, which has considerable implications for drug-related companies.