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Summary Judgment Federal Food Drug and Cosmetic Act (FFDCA) Pharmaceutical Industry

Foley Hoag LLP

Product Liability Update - April 2025

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Foley Hoag LLP publishes this quarterly Update primarily concerning developments in product liability and related law from federal and state courts applicable to Massachusetts, but also featuring selected developments for New...more

Fuerst Ittleman David & Joseph

Lilly v. FDA: Two Stories Collide to Make this GLP-1 Case a Tale of Our Time

I recently learned of Eli Lilly & Co.’s (“Lilly”) recent lawsuit against FDA from Nicole DeFeudis, who interviewed me for her Endpoints News story about the case. Lilly’s lawsuit, filed in September 2024 in the Southern...more

Foley & Lardner LLP

FDA Marketing Exclusivity Periods Limited To Same Active Moiety

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In Otsuka Pharm. Co., Ltd. v. Price, No. 16-5229 (D.C. Cir. Aug. 29, 2017), the U.S. Court of Appeals for the District of Columbia Circuit affirmed the district court decision upholding FDA’s “same moiety” test for defining...more

Foley Hoag LLP

Product Liability Update - July 2015

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Massachusetts Supreme Judicial Court Holds Failure-to-Warn Claim Against Drug Manufacturer Not Preempted Because There Was No “Clear Evidence” FDA Would Not Have Approved Plaintiffs’ Suggested Warning; Also Holds...more

Foley Hoag LLP

DC District Court Strikes Down 340B Orphan Drug Rule

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On May 23, Judge Contreras of the U.S. District Court for the District of Columbia (DC District Court) ruled that the Health Resources and Services Administration (HRSA) did not have the statutory authority to promulgate its...more

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