The first two sessions (May 13th and May 20th) will focus on the 505(b)(2) NDA pathway for US FDA submission, and will feature speakers that participated in SAAMnow’s successful workshop on Demystifying 505(b)(2) Development: Navigating the Scientific, Regulatory, Legal, and Business Complexities (October 16-18, 2019, Philadelphia, PA). The workshop highlighted the diversity, simplicity and complexity of the 505(b)(2) application process, and via these webinars we want to continue to fill the basic educational gap in understanding and characterizing the 505(b)(2) pathway by giving participants an opportunity to learn from experts in this field.
Webinar Session 2: Intellectual property and regulatory considerations for filing a 505(b)(2) NDA
Presenter 1: Barbara Binzak Blumenfeld, PhD, JD, MA, Attorney at Law, Buchanan Ingersoll & Rooney PC: Optimizing Your 505(b)(2) FDA Regulatory Strategy
Presenter 2: Matthew Fedowitz, JD, Attorney at Law, Buchanan Ingersoll & Rooney PC: Current Strategies for Obtaining, Maneuvering Around and Enforcing IP Involving 505(b)(2) Products
- Patent certification and intellectual property considerations for 505(j) and 505(b)(2) applications, including identifying Listed Drug and patents covering Listed Drug, developing your patent strategy and portfolio for Orange Book listed patents and non-Orange Book patents, navigating the appropriate certification to make, and timing of your 505(b)(2) NDA.
- Filing a 505(b)(2) NDA application: regulatory issues and approval requirements.
- Strategic considerations for a 505(b)(2) NDA, including business, development and marketing factors, and critical questions to consider in the scientific, medical, regulatory and market areas.