New, Emerging, and Continually Interesting Issues

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biologics, FDA protein definition, labeling carve-outs and carve-ins, authorized biosimilars, advertising and promotion draft guidance, purple book reform, and FDA’s umbrella policy for Reference Product (RP) exclusivity.

Scott M. Lassman, Principal, Lassman Law + Policy

This session was recorded as part of FDLI’s Introduction to Biological Products, Including Vaccines, Biosimilars, Cell and Gene Therapies, and Other Advanced Therapies Course in March 2022. 


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