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Open for comment Health and Human Services Department, Food and Drug Administration RIN 0910-AI94 Docket Docket No. FDA-2025-N-6075

FDA Proposes Streamlined Registration for Distributed Manufacturing Establishments

💬 Comments close in 40 days (Sep 11)

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Timeline

  1. Proposed / opened

    FDA Proposes Streamlined Registration for Distributed Manufacturing Establishments

  2. Related document

    Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments

Briefs in this proceeding

Notable FDA 💬 Comments close in 40 days (Sep 11)

FDA Proposes Rules for Distributed Manufacturing Registration and Foreign Establishment Alignment

FDA proposes to allow distributed manufacturers to register as a single establishment and align foreign establishment requirements with the PREVENT Pandemics Act. The FDA issued a proposed rule to amend drug establishment registration and drug listing requirements for two specific scenarios:...

Sources

Health and Human Services Department, Food and Drug Administration · Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments · Jul 13