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FDA proposes changes for distributed drug manufacturing registration

The agency has proposed a registration approach for advanced distributed manufacturers using a central quality hub and multiple production units. This is a regulatory or programme announcement; consult the original notice for the precise scope and status.

Published by
GEN — Genetic Engineering & Biotechnology News
Evidence type
Regulatory

GEN reports: The agency has proposed a registration approach for advanced distributed manufacturers using a central quality hub and multiple production units.

This is a regulatory or programme announcement; consult the original notice for the precise scope and status. Consult the linked GEN report for the source organisation’s full announcement.

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FDA proposes changes for distributed drug manufacturing registration | Brilliant Blue Biosciences