Pharma & Biologics Regulatory Submissions
IND vs. NDA: Understanding the Difference in FDA Submissions
For drug developers, FDA approval is a long and complex journey. Two of the most important milestones on this path are the Investigational New Drug (IND) application and the New Drug Application (NDA). While both are critical submissions, they serve very different purposes.
The FDA’s CMC Development and Readiness Pilot (CDRP) Program: What Sponsors Need to Know
In August 2023, the U.S. Food and Drug Administration (FDA) announced the launch of the Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program. This initiative is designed to help sponsors of certain accelerated development products better align their CMC strategies with the FDA early in the development process.
CMC Challenges in Cell & Gene Therapy: How to Avoid Regulatory Delays
In recent years, cell and gene therapies (CGTs) have transformed from scientific breakthroughs into commercial realities. These advanced modalities are redefining how we approach rare, genetic, and otherwise untreatable diseases—offering patients options that were once unimaginable. Yet, while the science is groundbreaking, the CMC (Chemistry, Manufacturing, and Controls) pathway remains one of the most significant obstacles to timely regulatory approval.
Why BLAs Are Different from NDAs
When it comes to bringing new therapies to patients in the U.S., two key FDA pathways are often discussed: New Drug Applications (NDAs) and Biologics License Applications (BLAs). While both serve the same ultimate goal—getting safe and effective treatments to market—they follow very different paths. Understanding the differences between NDAs and BLAs is crucial for companies developing new therapeutics, particularly as the biotech landscape continues to evolve.
How Do You Know When You’re Ready to Submit an IND? Part 1
Read about the core requirements for a successful IND submission, the strategic advantages of scheduling a pre-IND meeting, and how to prepare in a way that not only streamlines the review process but also reduces the risk of encountering a clinical hold.
