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# Pfizer Sees Potential Guidance Conflicts
- URL: https://www.fdaweb.com/pfizer-sees-potential-guidance-conflicts/
- Published: 2017-10-10T12:00:00.000Z
- Updated: 2026-09-14T22:55:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139829

Pfizer says there may be conflicts between an FDA draft guidance on chemistry, manufacturing, and controls postapproval manufacturing changes for specified biological products to be documented in annual reports, and other guidance documents. In its comment [letter](https://www.regulations.gov/document?D=FDA-2017-D-2802-0006&ref=fdaweb.com) on the draft, the company says it is difficult to determine which guidance would take precedence and under the draft, it is unclear if certain changes would be considered a reportable item. It suggests that the agency add a sentence to the draft effectively stating that in cases where there are differences in guidance around annual reportable items, the new guidance takes precedence over what is captured under the guidance “Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products.” Alternatively, it says, the two guidances should be harmonized as suggested in Pfizer’s detailed comments.

[Novartis](https://www.regulations.gov/document?D=FDA-2017-D-2802-0004&ref=fdaweb.com) makes recommendations for specific section and line changes, as does [AstraZeneca](https://www.regulations.gov/document?D=FDA-2017-D-2802-0003&ref=fdaweb.com).