FDA Proposes Rule to Modernize Drug Manufacturing Registration
The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would create a streamlined registration pathway for distributed manufacturing establishments that operate as a ...
Pharmaceutical Technology on MSN
Hub-and-spoke drug manufacturing set to benefit from new FDA rule
The proposed rule would allow multiple manufacturing units at different locations to register as one establishment.
US FDA proposes rule to simplify registration for some distributed drug manufacturers
FDA has proposed a rule to streamline registration for certain distributed drug manufacturing sites and ‌clarify reporting requirements for some foreign production facilities, as part ‌of its efforts ...
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 proposes rule to ease registration for distributed manufacturers, require foreign API sites to register
The US Food and Drug Administration (FDA) on Friday outlined a set of proposed reforms to advance modern manufacturing methods and increase supply chain visibility. In a proposed rule, the agency said ...
JD Supra
Reinventing the Wheel: FDA’s Hub-and-Spoke Fix for Drug Manufacturing Registration
On July 13, the US Food and Drug Administration (FDA) proposed a new rule that would fundamentally change how certain drug manufacturers ...
US FDA proposes new rule to simplify drug manufacturing registration
US FDA proposes a new rule to simplify drug manufacturer registration, improve supply chain transparency and strengthen oversight of global pharmaceutical networks.
FDA moves to expose hidden foreign drug factories, strengthen domestic production in sweeping rule proposal
The FDA's new website and regulatory overhaul aim to close a loophole that lets foreign factories hide raw drug materials from U.S. supply chain oversight.
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US FDA proposes rule to simplify registration for some drug manufacturers
July 10 (Reuters) - The U.S. FDA on Friday proposed a rule to streamline registration requirements for certain drug manufacturers that operate through a central hub and multiple production facilities, ...
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US FDA proposes rule to simplify registration for some distributed drug manufacturers
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly July 10 (Reuters) - The U.S. FDA has proposed a rule ...