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 IND is the “starting line,” allowing clinical trials to begin, while the NDA is the “finish line,” requesting FDA approval to market the drug. Understanding the distinction between these two submissions is essential for planning your regulatory strategy, timelines, and documentation needs.
What Is an IND?
The Investigational New Drug (IND) application is a sponsor’s formal request to the FDA for authorization to begin clinical trials in humans.
Key characteristics:
In short: an IND does not seek approval to market a drug, but rather permission to study it in people.
What Is an NDA?
The New Drug Application (NDA) is the formal request for FDA approval to market a drug in the U.S.
Key characteristics:
Unlike the IND, an NDA requests market approval—the final step before a new drug can be sold and prescribed.
Why the Difference Matters
Understanding where INDs and NDAs fit into the development continuum is critical:
The Role of Expert Regulatory Writing
Both INDs and NDAs demand precision, but the scope and complexity differ significantly.
At GLOBAL, our regulatory writers and consultants support sponsors across the full lifecycle—from first-in-human INDs to market-ready NDAs. With experience across therapeutic areas, we ensure that every submission communicates science clearly and meets FDA expectations.
Conclusion
The IND and NDA are two pillars of the U.S. regulatory process, each with a distinct role: one enables the study of a new drug in humans, and the other secures approval to bring it to market. Recognizing their differences—and planning accordingly—can mean the difference between costly delays and a smooth path to approval.
GLOBAL’s team of regulatory experts can help you prepare both INDs and NDAs with precision, ensuring that your program stays on track from first trial to final approval.
Contact us today to learn how we can support your IND and NDA 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.
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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.
