PDUFA VII: Assessment of FDA and Sponsor Communications Through Product Quality Information Requests

Background

Clear and effective communication between FDA staff and applicants during application review is important to ensuring transparent, predictable, effective, and efficient review. During the review of the product quality related information in an application, FDA may issue an information request (IR) for further information or clarification that is needed or would be helpful to allow completion of the review. IRs from CDER and CBER are expected to follow Four-Part Harmony in which reviewers are expected to communicate: (1) what was provided, (2) what is the issue or deficiency, (3) what is needed, and (4) why it is needed. The PDUFA VII goals letter includes commitments for FDA to update and conduct training on policies and procedures to reflect Four-Part Harmony. FDA also committed to contracting with an independent third party to assess the practices of CDER, CBER and sponsors in communicating through product quality IRs during application review to ensure the effectiveness of Four-Part Harmony.

Opportunity for Public Comment

Per the PDUFA VII commitment letter, FDA is announcing an opportunity for public comment on the final report for the third-party assessment of product quality IRs and Four-Part Harmony. FDA is requesting feedback on: (1) the assessment findings and recommendations, (2) whether certain recommendations are more desirable than others, and (3) other actions FDA and applicants should consider and why.

The public can access the final report here.

The public can view the Federal Register Notice and provide comments on the final report via the Federal Register. The public comment period closes on July 31, 2025. 

Resources

• PDUFA VII and the PDUFA VII goals letter
• Statement of Work

Contact

Mahesh Ramanadham: Mahesh.Ramanadham@fda.hhs.gov