FDA to Use DUNS Numbers as UFIs for FDASIA Drug Facility Registration
The Food and Drug Administration intends to use DUNS numbers assigned by Dun and Bradstreet as Unique Facility Identifiers for domestic and foreign drug facility registration required by the Food and Drug Administration Safety and Innovation Act (FDASIA), it said…
Sign up for a free preview to unlock the rest of this article
Timely, relevant coverage of court proceedings and agency rulings involving tariffs, classification, valuation, origin and antidumping and countervailing duties. Each day, Trade Law Daily subscribers receive a daily headline email, in-depth PDF edition and access to all relevant documents via our trade law source document library and website.
in a draft guidance (here) posted Sept. 4. DUNS numbers (here) are free and are already widely used for drug registration, and meet agency needs, FDA said. The draft guidance only applies to registration requirements found in Sections 701 and 702 of FDASIA, and not to registration requirements for excipient manufacturers in Section 703 of the law. Comments on the draft guidance are due by Nov. 5