Federal Register #FDA-2026-N-0809

FDA Reopens Comment Period for Industry Guidance on Scale-Up and Postapproval Changes

This opportunity is a public notice from the Food and Drug Administration (FDA) seeking stakeholder input on industry guidances: - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - No Original Equipment Manufacturers (OEMs) or vendors are mentioned - No products or services are being requested or procured - The notice requests comments and information from stakeholders regarding guidances on scale-up and postapproval changes for specific dosage forms - Unique requirement: - Submission of comments and information related to the guidances - Instructions provided for both electronic and written submissions - No part numbers, quantities, or procurement actions are specified

Description

The Food and Drug Administration (FDA) is reopening the comment period for its request for information and comments on the Agency's series of guidances for industry regarding scale-up and postapproval changes for specific dosage forms. This action allows interested persons additional time to submit comments. The original notice was published on March 3, 2026, and the comment period is extended until July 13, 2026. Comments can be submitted electronically or in writing as detailed in the notice.

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