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US Agency Opens Up ICH Q13 Draft Guidance For Comment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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Deal Watch: J&J Begins 2022 With Trio Of Technology Alliances
Heading into the J.P. Morgan Healthcare conference, pharmas have been focusing on discovery alliances. J&J’s deals look into novel tissue-targeted drugs, ionic liquid delivery technology and cancer vaccine R&D. Lilly teams with Entos on novel methods for delivering neurology drugs.
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.
Generics Firms Deterred From Continuous Manufacturing
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.