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 2021. 



Get Access

  • +$100 for nonmembers

Virtual Learning FAQ

On-demand webinar content is sent via email as soon as we are able to process and verify your order. This usually occurs within 1 business day.


On-demand content can be played back on most devices.


CLE credit is not currently available for pre-recorded sessions.

Related Content