Drug Establishment Registration & Listing (FDA)
Current understanding
FDA regulates the registration of drug manufacturing establishments and the listing of drugs under FD&C Act sections 510 and related provisions. A proposed rule would allow distributed manufacturing operations spanning multiple physical locations to register as a single establishment and would conform foreign drug establishment registration requirements to the PREVENT Pandemics Act. Status: proposed rule.
Evidence log
Open questions
Related
Contributing findings
Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
13-jul-2026
novelty 2
per-area 2
introduces