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Food and Drug Administration (FDA) Exhaustion Doctrine

Harris Beach PLLC

Doe v. Merck: Vaccine Autism Lawsuit Dismissed as Baseless

Harris Beach PLLC on

The claim that the MMR vaccine caused autism was meritless on its face, held the U.S.D.C., Eastern District of New York (Doe v. Merck & Co, Inc.). The action filed on behalf of “Baby Doe” stemmed from Merck-manufactured...more

Patterson Belknap Webb & Tyler LLP

Nearly Two Years After Dismissal of its Declaratory Judgment Action, FDA Accepts for Review Sandoz’s Application for a Biosimilar...

Sandoz Inc. announced on October 2, 2015 that FDA accepted its regulatory application for a proposed biosimilar of Amgen Inc.’s biologic arthritis drug Enbrel for review. The acceptance comes years after Sandoz attempted to...more

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