Webinar: Intellectual property and regulatory considerations for filing a 505(b)(2) NDA
May 20 2020
11:00 AM - 1:00 PM
Barbara Binzak Blumenfeld, shareholder in the firm's Life Sciences section and Matthew Fedowitz, shareholder in the firm's IP section, will participate in a webinar hosted by Scientists Advancing Affordable Medicines, Inc. (SAAMnow).
They will discuss: Optimizing Your 505(b)(2) FDA Regulatory Strategy and 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.