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

FDA Law Blog

According to AstraZeneca, the statute defines a qualifying single source drug by reference to its individual “approval,” and “any other reading. 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. Opinion at 17. see also 42 U.S.C.