Executive Summary
FDA submissions have grown longer and more complex by a factor of seven over the last two decades, as the agency has shifted from a document-centric review model to a data-centric one.
An NDA today can exceed 100,000 pages. CDRH processed over 20,700 medical-device submissions in 2024. The eCTD format that anchors pharmaceutical filings is mid-transition to its 4.0 specification, with new submission-readiness and data-traceability expectations. The cumulative effect is that submission preparation has become a project of an entirely different scale than it was twenty years ago.
This paper tracks the longitudinal growth of submission complexity (2005–2025) and identifies the structural drivers behind it — informing where AI infrastructure can be most usefully applied.
Key Findings
- Average submission length has grown approximately 7× since 2005.
- Major NDAs routinely exceed 100,000 pages of source content.
- FDA CDRH processed over 20,700 medical-device submissions in 2024.
- The eCTD 4.0 transition introduces new data-traceability and submission-readiness expectations.
- Complexity growth is driven by expanding therapeutic-area guidance, post-market surveillance requirements, and cybersecurity / AI/ML content expectations.
Read the full analysis
The full white paper — including methodology, source citations, and detailed analysis of each finding — is available as a downloadable PDF.