FDA Proposes New Rule Streamlining Registration for Hub-and-Spoke Drug Manufacturing
The U.S. Food and Drug Administration (FDA) has proposed a new rule to simplify registration requirements for drug manufacturers using a 'hub-and-spoke' model, allowing them to register as a single facility rather than individually registering each unit. This change aims to reduce administrative burdens while improving the FDA's visibility into global supply chains.
Topics: pharmaceutical manufacturing regulatory reform supply chain efficiency