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FDA Seeks Feedback On Continuous Manufacturing

US Agency Opens Up ICH Q13 Draft Guidance For Comment

Executive Summary

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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Phlow Partners With USP On Continuous Manufacturing

Phlow Corp has announced a strategic alliance with the US Pharmacopeia to certify and validate continuous manufacturing processes as it aims to bolster US supplies of essential medicines. The company believes the move could serve as a catalyst for wider generics industry adoption of continuous manufacturing.

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Rutgers University professor testifies in support of bill directing the FDA to designate National Centers of Excellence in Continuous Manufacturing; other bills target generic labeling, orphan exclusivity and counterfeit devices.

FDA Invites Comment On Continuous Manufacturing

Draft guidance on quality considerations for continuous manufacturing has been published by the US Food and Drug Administration with a 90-day comment period.

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