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# Comments Sought on Biologic Adverse Event Reporting
- URL: https://www.fdaweb.com/comments-sought-on-biologic-adverse-event-reporting/
- Published: 2017-07-18T12:00:00.000Z
- Updated: 2026-09-14T22:34:47.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139162

*Federal Register* notice: FDA is seeking comments on an information collection extension for “Adverse Experience Reporting for Licensed Biological Products; and General Records — 21 CFR Part 600.” The regulation requires licensed manufacturers to report each adverse experience that is both serious and unexpected, whether foreign or domestic, as soon as possible but in no case later than 15 calendar days of initial receipt of the information. Follow-up reports are required within 15 calendar days of receipt of new information or as requested by FDA. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-07-18/pdf/2017-15004.pdf?ref=fdaweb.com).