JD Supra

FDA Proposes New Drug Manufacturing Rule: What Distributed Manufacturing and Foreign API Registration Changes Could Mean for Pharma Compliance

In the wake of the Food & Drug Administration’s (FDA) ambitious unified agenda, on July 13, 2026, the agency published a proposed rule aiming to align its regulatory frameworks with “how distributed ...
RAPS

FDA Selects Unique Facility Identification System for Registration of Drug Facilities Under FDASIA

A new cross-center draft guidance document released by the US Food and Drug Administration (FDA) established the agency's preferred unique facility identification (UFI) system used to register ...
arcweb

U.S. FDA Proposes Updated Registration Framework for Distributed Drug Manufacturing

Proposed changes would streamline hub-and-spoke manufacturing registration and improve visibility into foreign pharmaceutical supply sources. The U.S. Food and Drug Administration (FDA) has proposed a ...