Amy Speros

Amy Speros

Latham & Watkins LLP

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

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

10/10/2016  /  Abbreviated New Drug Application (ANDA) , FDA Approval , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Orange Book , Pharmaceutical Patents
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