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# ‘Good Cause’ Guidance Needs Flexibility: PhRMA
- URL: https://www.fdaweb.com/good-cause-guidance-needs-flexibility-phrma/
- Published: 2023-09-13T12:00:00.000Z
- Updated: 2026-09-14T18:56:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155323

Commenting on an FDA draft guidance on determining “good cause” for noncompliance with postmarketing requirements, Pharmaceutical Research and Manufacturers of America (PhRMA) [says](https://downloads.regulations.gov/FDA-2023-D-0559-0007/attachment%5F1.pdf?ref=fdaweb.com) it is concerned that the proposed standard for “good cause” is unduly inflexible. The trade association recommends that the draft be revised “to account for a totality of circumstances approach to the assessment of good cause.”

PhRMA also recommends that FDA revise the guidance’s examples of postmarketing requirement noncompliance that FDA would or would not consider reasonable to discuss other common reasons for delay with good cause, align with past agency guidance, and better fit the proposed “good cause” standard.