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NoticeOpen for Comment2026-116902026-06-11

Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments; Reopening of the Comment Period

Health and Human Services Department, Food and Drug Administration

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.

Action & Dates

Action
Notice; request for information and comments; reopening of the comment period.
Dates
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.

Public Comment

Comments Close
2026-07-13 — Open for comment

Document Excerpt

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2026-N-0809] AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for information and comments; reopening of the comment period. SUMMARY: 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. DATES: 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. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 13, 2026. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. Electronic Submissions Submit electronic comments in the following way: Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions for submitting comments. Comments submitted electronically, incl

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Related Documents

Other Federal Register documents from the same docket.

Full Document

Citation: 91 FR 35483