American Conference Institute's 42nd Boot Camp: FDA Boot Camp

Partner Maarika Kimbrell will be presenting as part of the ACI’s FDA Boot Camp, leading the discussion on Hatch-Waxman and the Biologics Price and Innovation Act of 2009 (BPCIA). During her presentation, Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entry, Maarika will give critical insights for both drug manufacturers and biologics developers. Maarika's presentation will take place on Wednesday, March 13th, 2024 at 3:45 PM EST.

For drug manufacturers, the presentation will cover various options for New Drug Applications and what factors applicants should consider during drug development. The talk will also encompass valuable information for biologics and biosimilar manufacturers, including a comprehensive walkthrough of the BPCIA.