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

Activity

Association for Accessible Medicines filed 1 comment on this docket between Sep 21, 2026 and Sep 21, 2026. 6 other organizations filed here. The comment window closed 55d ago.

What Association for Accessible Medicines filed (1)

Abstract

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the drug establishment registration and drug listing requirements with respect to establishments engaged in distributed manufacturing and foreign drug establishments. This action, if finalized, will provide a pathway for a distributed manufacturing establishment that manufactures drugs at multiple different physical locations to register as a single drug manufacturing establishment and align drug establishment registration and drug listing regulations applicable to foreign drug establishments with statutory changes made by the Preparing for and Responding to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act).

• Association for Accessible MedicinesTHIS ORG

  1 filing · confidence 97%
• Alliance for Regenerative Medicinetrade assoc.

  1 filing · confidence 85%
• America First Policy Institutetrade assoc.

  1 filing · confidence 85%
• American Society of Ophthalmic Traumatrade assoc.

  1 filing · confidence 85%
• Compressed Gas Associationtrade assoc.

  1 filing · confidence 85%
• DEKA Research and Development Corporationunverified attribution

  1 filing · confidence 70%
• Siemens Corporationunverified attribution

  1 filing · confidence 70%