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Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments; Reopening of the Comment Period
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Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the request for information and comments that appeared in the Federal Register of March 3, 2026. In the notice, FDA requested comments on the Agency's series of guidances for industry on scale-up and postapproval changes for specific dosage forms. The Agency is taking this action to allow interested persons additional time to submit comments.
- Document type
- Notice
- Federal Register document number
- 2026-11690
- Published
- Jun 11, 2026
- Action
- Notice; request for information and comments; reopening of the comment period.
- Docket
- FDA-2026-N-0809
- Comments posted on Regulations.gov (at last check)
- 0
- DATES section (from the document)
- FDA is reopening the comment period on the request for information and comments published on March 3, 2026 (91 FR 10397). Either electronic or written comments must be submitted by July 13, 2026.
- Topics (auto-tagged)
- CMC (chemistry, manufacturing & controls)
Source: Federal Register API, document 2026-11690. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.