Biologics License Applications (BLA): An Introduction

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. 



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