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# Direct Rule on Biologics Inspections Withdrawn
- URL: https://www.fdaweb.com/direct-rule-on-biologics-inspections-withdrawn/
- Published: 2018-05-07T12:00:00.000Z
- Updated: 2026-09-15T00:03:08.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141370

*Federal Register* notice: FDA has withdrawn a 1/26/2018 direct final rule to amend its general biologics regulations relating to time of inspection requirements and to also remove duties of inspector requirements. The withdrawal is necessary after FDA received significant adverse comment against the proposal. The agency will now proceed with formal notice and comment rulemaking to effect the changes. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-05-07/pdf/2018-09589.pdf?ref=fdaweb.com).