What Recent FDA CRLs Reveal About CMC: A Conversation With Our Global Head Of Field Development, Amy Glekas, Ph.D.

By Amy Glekas, Ph.D., Senior Director, Global Head of Field Development

The FDA's recent release of Complete Response Letters (CRLs) has given the industry valuable insight into the most common reasons drug applications fall short of approval. While every program is different, many CRLs highlight recurring CMC challenges that can be identified and addressed much earlier in development.

In this Q&A, our Global Head of Field Development, Amy Glekas, Ph.D., discusses the key lessons developers can learn from recent CRLs and shares practical strategies for strengthening regulatory submissions, including:

• Why CMC deficiencies remain one of the leading causes of FDA Complete Response Letters
• Common development gaps that can delay approval
• How analytical and CMC planning can help reduce regulatory risk
• The value of cross-functional collaboration throughout drug development
• Practical steps for building more regulatory-ready submissions