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.

Andrew Papas, Vice President of Regulatory Affairs, Pharma Biotech, NSF International

This session was recorded as part of FDLI’s Virtual Introduction to Biologics and Biosimilars Laws and Regulations Course in October 2021. 



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