The U.S. Food and Drug Administration (“FDA”) issued a proposed rule to update drug establishment registration and listing requirements for distributed manufacturing (“DM”) and certain foreign drug establishments. If finalized, the rule would create a streamlined registration pathway for qualifying distributed manufacturing establishments (“DMEs”) that manufacture drugs at multiple physical locations, while also aligning... READ MORE
FDA Proposes Distributed Manufacturing Registration Pathway and Aligns Foreign Establishment Registration and Listing Requirements With Current Law
Posted on July 29, 2026 in Health Law News
Published by: Hall Render