RegulatoryGuideline · final

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

🇺🇸 FDA · Thu 11 Jun 2026

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.

Official guideline text: FDA ↗

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