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# Clarify Refuse-to-File Guidance: PhRMA
- URL: https://www.fdaweb.com/clarify-refuse-to-file-guidance-phrma/
- Published: 2018-02-14T12:00:00.000Z
- Updated: 2026-09-14T23:22:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140758

Pharmaceutical Research and Manufacturers of America (PhRMA) says it believes an FDA draft guidance on refusal to file NDA and BLA submissions to CDER will help manufacturers prepare complete applications that are ready for filing, reducing burdens on industry and the agency both. But it also [says](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-D-6554-0003&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) that some aspects of the draft guidance should be clarified.

In particular, the comment letter says, the draft guidance focuses on FDA’s policy for refusing to file an NDA and suggests that the reasons specified in the appropriate regulations likewise apply to BLAs. “PhRMA also believes that certain recommendations in the draft guidance relating to ‘review’ issues serving as the basis for a refuse-to-file decision should be clarified,” it says.

The association asks that the draft guidance be revised on applications that are filed over protest to reflect the PDUFA 6 commitment letter, since the draft cites an outdated version of the PDUFA performance goals and should reflect the new commitment letter.