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# CMC Guidance Clarifications Sought
- URL: https://www.fdaweb.com/cmc-guidance-clarifications-sought/
- Published: 2017-10-11T12:00:00.000Z
- Updated: 2026-09-14T22:55:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139842

The Biotechnology Innovation Organization (BIO) says that FDA could minimize ambiguity when it finalizes a draft guidance, “Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products to Be Documented in Annual Reports,” by giving examples of situations where annual reportable listed changes in the guidance may be better categorized by applicants as a supplement, based on specific circumstances. The group’s comment [letter](https://www.regulations.gov/document?D=FDA-2017-D-2802-0014&ref=fdaweb.com) also says it would be helpful for the agency to acknowledge and confirm that a sponsor can perform an impact assessment to determine if a proposed change may be reported in an annual report, even if the proposed change is not listed in the guidance. BIO includes other general comments and specific line-by-line comments.

The Pharma & Biopharma Outsourcing Association [says](https://www.regulations.gov/document?D=FDA-2017-D-2802-0009&ref=fdaweb.com) the guidance does not define opportunities for postapproval change regulatory relief, such as allowing more annual reportable changes versus changes-being effected-type changes, related to such initiatives as the agency’s draft guidance on quality metrics. The association says it recommends that the draft guidance could be used to outline FDA’s philosophy on reduced postapproval change regulatory requirements.