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FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

FDA Law Blog

This FR Notice and draft strategy document are part of FDA’s commitment under the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures for Fiscal Years 2023-2027 (PDUFA VII), wherein FDA committed to advance the use and implementation of innovative manufacturing.

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AstraZeneca’s Challenge to Price Negotiation Fails in Federal District Court

FDA Law Blog

To the extent that AstraZeneca alleged that CMS would cause it this type of harm in 2027, the court found that allegation to be too speculative. Ill (14 July 2023) WITHDRAWN N/A (No drugs selected for Year 2026) Tex (21 June 2023) N/A (Trade Associations representing manufacturers) Amgen NO LAWSUIT Enbrel Astellas N.D.