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# Comments on COA Guidance
- URL: https://www.fdaweb.com/comments-on-coa-guidance/
- Published: 2022-09-29T12:00:00.000Z
- Updated: 2026-09-14T18:01:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152857

Pharmaceutical Research and Manufacturers of America suggests several ways FDA could improve its draft guidance on selecting, developing, or modifying fit-for-purpose clinical outcome assessments. The association’s comment [letter](https://www.regulations.gov/comment/FDA-2022-D-1385-0037?ref=fdaweb.com) calls for changes to expand the guidance’s scope and provide consistency in terminology across the agency’s patient-focused drug development guidance series.

GlaxoSmith Kline [says](https://www.regulations.gov/comment/FDA-2022-D-1385-0036?ref=fdaweb.com) it welcomes the draft guidance because it provides sponsors with recommendations on how patient experience data may be collected and submitted for medical product development and regulatory decision-making. It makes general and specific recommendations for changes to the document.

The Regeneron comment [letter](https://www.regulations.gov/comment/FDA-2022-D-1385-0031?ref=fdaweb.com) lists proposed changes “to assist the agency in enhancing the utility of the draft guidance.”

Bristol-Myers Squibb [submitted](https://www.regulations.gov/comment/FDA-2022-D-1385-0039?ref=fdaweb.com) line-by-line specific comments.