2026-11690Notice

FDA Extends Comment Deadline on Drug Scale-Up Rules

Published Date: 6/11/2026

Notice

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.

No Economic Impacts Identified for this Document

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Key Dates

Published Date
Comments Due
6/11/2026
7/13/2026

Department and Agencies

Department
Independent Agency
Agency
Health and Human Services Department
Food and Drug Administration
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