Assess historical and current standards of approval. Discuss what standard FDA uses to approve a BLA submitted under section 351(a) of the Public Health Service Act (PHSA). Outline what is in section 351(a) BLA. Understand FDA’s review and decision processes.
Christina M. Markus, Partner, King & Spalding LLP
This session was recorded as part of FDLI’s Virtual Introduction to Biologics and Biosimilars Laws and Regulations Course in March/April 2020.