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Pharmaceutical Industry › Food and Drug Administration (FDA) › Disclosure

Arnall Golden Gregory LLP

This is a Land of Confusion: FDA Issues Q&A Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs

Arnall Golden Gregory LLP on

In 1986, from the Invisible Touch album, the rock band Genesis sang a song about “Land of Confusion” (remember the weird video with puppets?). Almost 40 years later, in July 2024, the Food and Drug Administration issued a...more

MoFo Life Sciences

Federal Court Invalidates Dosing Patent Based On Clinical Trials Disclosure

MoFo Life Sciences on

As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in...more

Wilson Sonsini Goodrich & Rosati

Federal Circuit Amgen Case Clarifies Important Aspects of the Biologics Price Competition and Innovation Act

Wilson Sonsini Goodrich & Rosati on

On July 21, 2015, the U.S. Court of Appeals for the Federal Circuit issued its holding in Amgen Inc. v. Sandoz Inc., 2015-1499 (Fed. Cir. 2015). The Federal Circuit's decision is the latest development in the long-running...more

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