What FDA CRLs Reveal About Stability

A longer shelf life can mean greater flexibility in manufacturing and distribution, more control over inventory, and greater resilience across the supply chain. But when the shelf life you want gets ahead of the data you have, the regulatory risk can outweigh the potential commercial benefit. That regulatory risk is far from theoretical. In our latest analysis of FDA Complete Response Letters (CRLs), we found that 14% included stability-related deficiencies.

Download our white paper to learn what issues are driving these CRLs and how to build a stronger stability testing program.