Health and Human Services Department Docket FDA-2023-N-1259 Notice

2023-08545: Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches; Public Workshop; Request for Comments

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Summary

The Food and Drug Administration (FDA, the Agency, or we), in cosponsorship with the Duke-Margolis Center for Health Policy, is announcing a public workshop entitled "Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches." This workshop will address innovative manufacturing technologies for drug and biological products and will include a discussion of potential best practices, case studies from previous submissions, potential barriers to adoption, corresponding regulatory strategies, and the Advanced Manufacturing Technologies Designation Program.

The agency’s own summary, as published.

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