2027, Illness and IT - Primary Care Digest

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2027

Illness

FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

FDA Law

SEPTEMBER 16, 2024

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.

Manufacturing

Manufacturing IT Supply Chain Provider

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

FDA Law

MARCH 5, 2024

By Faraz Siddiqui — Last Friday, the Delaware District Court rejected AstraZeneca’s lawsuit against the Medicare Drug Price Negotiation Program enacted under the Inflation Reduction Act (IRA) and CMS’s guidance implementing it. Opinion at 17. contradicts the plain text of the statute and therefore must be set aside.” see also 42 U.S.C.

Government

Government IT Manufacturing Illness

FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

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

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