# 2026-11690: FDA Extends Comment Deadline on Drug Scale-Up Rules

2026-11690, Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments; Reopening of the Comment Period, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-06-11, effective 2026-07-13 (as of 2026-06-18).

- Canonical: https://policyrisk.com/federal-register/2026-11690
- As of: 2026-06-18
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-11690
- Title: Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments; Reopening of the Comment Period
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 35483
- Published: 2026-06-11
- Effective: 2026-07-13
- Comments close: 2026-07-13
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-18

## In one line

FDA Extends Comment Deadline on Drug Scale-Up Rules

## Summary

The FDA is giving companies more time to share their thoughts on new rules about making and changing medicines after approval. This affects drug makers who want to scale up production or tweak their products. Comments are open until July 13, 2026, so businesses should act fast to help shape these important guidelines that could impact costs and timelines.

## 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.

## Effects PRIA read

No economic effects identified for this document.

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## Sources
- [2026-11690 on federalregister.gov](https://www.federalregister.gov/documents/2026/06/11/2026-11690/recommendations-on-scale-up-and-postapproval-changes-guidances-for-industry-request-for-comments)
- [2026-11690 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-06-11/pdf/2026-11690.pdf)

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Source: PRIA, https://policyrisk.com/federal-register/2026-11690 (as of 2026-06-18).