Articles tagged with “biologics-license-application”

FDA Pre-License Inspection (PLI): A Guide for Biologics

Explore the FDA Pre-license Inspection (PLI) process for biologics. This guide explains the PLI's purpose, scope, and cGMP requirements for BLA approval.

30 min read

11/16/2025

pre-license inspection fda inspection biologics license application cgmp regulatory compliance biomanufacturing pli vs pai