Impact of the Omnibus Bill on the Generics Industry
1:15 p.m. - 2:30 p.m.
The Food and Drug Omnibus Reform Act of 2022 (FDORA) contains notable reforms to FDA’s statutory authority and the regulatory framework. Many of the provisions call for implementation and interpretation by FDA through regulations or guidance documents. This session will outline how the upcoming implementation of initiatives in the law will impact the generic industry, especially with regard to foreign inspections, therapeutic equivalence evaluations for 505(b)(2) products, diversity action plans for clinical studies, and enhancing access to affordable medicines.
Speakers:
Sara W. Koblitz, J.D.
Director, Hyman, Phelps, & McNamara, P.C.
Katlin McKelvie Backfield, J.D.
Former Deputy General Counsel, U.S. Department of Health and Human Services
Moderator:
Howard Sklamberg, J.D.
Partner, Arnold & Porter Kaye Scholer LLP
