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Abbreviated New Drug Application (ANDA) Medicare Modernization Act Generic Drugs

Robins Kaplan LLP

The FDA Implements the Medicare Modernization Act: A New Role and a New Mission?

Robins Kaplan LLP on

The Food and Drug Administration (FDA) has finally—after thirteen years—issued its final rule to amend its current regulations and implement the Medical Modernization Act governing how the American public get their generic...more

McDonnell Boehnen Hulbert & Berghoff LLP

Apotex Inc. v. Daiichi Sankyo, Inc. (Fed. Cir. 2015)

Can a Federal district court ever have subject-matter jurisdiction to hear a declaratory judgment action of non-infringement for a disclaimed patent? Of course, the Federal Circuit explained this week in the Apotex Inc. v....more

McDonnell Boehnen Hulbert & Berghoff LLP

FTC Releases Another Report on Reverse Payment Settlement Agreements in ANDA Litigation

As it has frequently in the past decade, the Federal Trade Commission on Thursday released a Report on the frequency of reverse payment settlement agreements in ANDA litigation between generic and branded drug makers,...more

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