Original air date: 12/6/16. FDA's New Final Rule Implementing the MMA and Amending ANDA and 505(b)(2) Practice. A presentation from the Food & Drug Committee.
More than a decade after Congress passed the Medicare Modernization Act of 2003 (MMA), the Food and Drug Administration (FDA) issued a new final rule that comprehensively revises FDA regulations governing 505(b)(2) applications and abbreviated new drug applications (ANDAs) as of December 5th. These amendments will apply to submissions received by FDA on or after that date, and provides new procedures and deadlines for patent listings and delistings, patent certifications and notice letters, and labeling carve outs, among other changes. Aspects of the rule will also impact exclusivity. This webinar will introduce key aspects of the new rule and analyze what these changes mean for pharmaceutical companies, as well as how companies may attempt to use the new rules to their strategic advantage. Speakers:
Brian R. McCormick, General Counsel - Regulatory and Lifecycle, Teva Pharmaceuticals;
Chad Landmon, Partner and Chair of IP and FDA Practice Groups, Axinn Veltrop & Harkrider LLP; moderated by
Shana K. Cyr, Ph.D., Attorney, Finnegan Henderson Farabow Garrett & Dunner, LLP.