Interested stakeholders have until 13 December 2021 to submit comments on draft International Council for Harmonisation guidance that the US Food and Drug Administration has published for feedback.
FDA Seeks Feedback On Continuous Manufacturing
US Agency Opens Up ICH Q13 Draft Guidance For Comment
A draft ICH guidance on continuous manufacturing has been opened up for comment by the FDA, as continuous manufacturing becomes an increasingly prominent topic for the generics industry.

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Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.