Newsletter | February 25, 2025

02.25.25 -- 2024 Trends In FDA Observations For Sterile Drug Manufacturers

FEATURED EDITORIAL

2024 Trends In FDA Observations For Sterile Drug Manufacturers

By Marzena Ingram, Eliquent Life Sciences; Ajay Pazhayattil, Ph.D., cGMPWorld; Prasanna Sagar, Ph.D., ITAAN Pharma; and Subrata Chakraborty, Ph.D., INOPHAR Consulting

This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?

Lab Manual Gaps: Sabotaging Data One Sample At A Time

By Elena Sinclair, FlexPoint Bio

In part two of this series on lab manuals, FlexPoint Bio Founder and CEO Elena Sinclair discusses the criticality of sample and process quality.

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