FDA presents route to improve operational efficiency of drug manufacturing
Proposal aims to modernise registration for distributed drug manufacturers, strengthening real-time transparency across the pharmaceutical supply chain.
The US Food and Drug Administration is proposing a new, streamlined drug manufacturing registration pathway to improve its visibility into upstream supply chains.
If finalised, under the proposed rule, distributed manufacturing establishments could register as a single establishment, rather than the current siloed model where each manufacturing unit is required to register separately.
FDA anticipates that having a central quality oversight hub and multiple equivalent manufacturing units at different locations will…
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