Exploring New FDA Initiatives

September 20, 2023 8:30am

Torrey Cope
Sidley Austin LLP
(Washington, DC)

Kurt R. Karst
Hyman, Phelps & McNamara, P.C. (Washington, DC)

This panel will discuss recent changes made to the law by the FDA User Fee Reauthorization Act of 2022, and the Food and Drug Omnibus Reform Act of 2022, including with respect to clinical trials and accelerated approval. In addition, the panel will highlight recent litigation against FDA and pending legislation of significance.