As part of the sixth authorization of the Prescription Drug User Fee Act, the U.S. Food and Drug Administration (FDA) committed to a third-party assessment of current combination product review practices, to include an information collection through engagement of FDA staff and individual sponsors of combination products. FDA has enlisted an independent contractor, Eastern Research Group, Inc. (ERG) for this purpose. The contractor proposes to conduct interviews with combination product sponsors and applicants to understand their perspectives on what is working well, challenges and pain points, lessons learned, and opportunities for improvement in submissions and reviews. The contractor will develop anonymized aggregated summaries of interview responses, analyze this information to identify common themes, consider these results along with submission data and feedback from FDA reviewers to develop a set of findings and recommendations, and prepare an assessment report for publication on the Agency’s public website.
The latest form for Assessment of Combination Product Review Practices expires 2022-03-31 and can be found here.
Supporting Statement B
Supporting Statement A
Approved without change
|New collection (Request for a new OMB Control Number)||2019-02-14|
Federal Enterprise Architecture: Health - Health Care Services