FDA announces opportunity for public comment on statement of work for PDUFA VII assessment

The U.S. Food and Drug Administration is announcing an opportunity for public comment on the statement of work (SOW) to assess communication between the FDA and sponsors through product quality information requests (IRs) during original new drug application and biologics license application review.

The assessment intends to identify best practices and areas of improvement in communications between FDA review staff and sponsors through product quality IRs during the application review portion of the human drug review program. Specifically, the assessment will examine the agency’s compliance with the application of “Four-Part Harmony” in product quality IRs, in which reviewers are expected to communicate:

  • What was provided;
  • The issue or deficiency;
  • What is needed; and
  • Why it is needed.

The goals of the assessment are described within the Prescription Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years 2023 through 2027 (“PDUFA VII”) document and are a part of the agency’s performance commitments under PDUFA VII. As mandated by the PDUFA VII performance commitments, an independent contractor will conduct the assessment; however, public stakeholders will have the opportunity to provide feedback on the SOW before it is revised to request contractor proposals.

For more details about the SOW for this assessment, including how to submit comments to FDA, visit FDA’s webpage