Recorded March 10, 2021 | On-Demand Webinar
Discuss emerging issues in transitional biologics, FDA protein definition, labeling carve-outs and carve-ins, authorized biosimilars, advertising and promotion draft guidance, purple book reform, and FDA’s umbrella policy for Reference Product (RP) exclusivity.
his session was recorded as part of FDLI’s virtual Introduction to Biologics and Biosimilars Law and Regulation course in March 2021.