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Orange Book › FDA Approval › Federal Food Drug and Cosmetic Act (FFDCA)

Axinn, Veltrop & Harkrider LLP

FTC Peeling Back the Layers of the Orange Book

Axinn, Veltrop & Harkrider LLP on

The Federal Trade Commission (FTC) is continuing to pursue pharmaceutical manufacturers for allegedly improperly listing patents in the “Orange Book,” delaying the entry of generic drug competitors. On May 21, the FTC...more

Latham & Watkins LLP

FDA Issues Final Rule on Abbreviated New Drug and 505(b)(2) Applications

Latham & Watkins LLP on

New rules affecting new drug application holders and follow-on applicants will take effect on December 5, 2016. On October 6, 2016, the US Food & Drug Administration (FDA or the Agency) published a 79-page final rule...more

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