“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. The proposed rule would allow multiple manufacturing units at different locations to register as one establishment. The hub-and-spoke model, which is a common blueprint in the pharma supply chain, involves multiple equivalent manufacturing units at different locations off-shooting from a central hub responsible for quality management. Credit: marekuliasz/Shutterstock.com. The US Food and Drug Administration (FDA) has proposed a new rule that will simplify the registration step for certain drug manufacturers with multiple facilities. The new framework, which is yet to be finalised, will allow…

Source: Clinical Trials Arena