Biologics License Applications (BLA): An Introduction

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Recorded March 31, 2020 | On-Demand Webinar

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 a section 351(a) BLA. Understand FDA’s review and decision processes.

This session was recorded as part of FDLI’s virtual Introduction to Biologics and Biosimilars Law and Regulation course in March 2020.

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