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# Combination Product Review Practices Work Well: Report
- URL: https://www.fdaweb.com/combination-product-review-practices-work-well-report/
- Published: 2020-09-01T12:00:00.000Z
- Updated: 2026-09-14T16:27:16.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5147560

An assessment of combination product review practices under PDUFA 6 indicates that the practices are generally considered by the product sponsors and agency reviewers to be effective and efficient despite some challenges. The just-released 8/7 [assessment](https://www.fda.gov/media/141519/download?ref=fdaweb.com) by Lexington, MA-based Eastern Research Group, Inc. says: 

- request for determination (RFD) and pre-RFD review practices are fundamentally sound and could be enhanced by some straightforward refinements;
- the Inter Center Consult Request process is fundamentally sound and could be made more efficient by addressing technology challenges and implementing some good practices; and
- combination product IND, NDA, and BLA submission and review practices are largely similar to those of noncombination products and are fundamentally sound and could be enhanced by implementing minor refinements to certain guidances and practices.

The assessment by an independent third-party was one of the FDA commitments under the PDUFA 6 reauthorization.