Leveraging Blockchain for Enhanced Data Integrity in FDA Submissions

Leveraging Blockchain for Enhanced Data Integrity in FDA Submissions

In 2025, the U.S. Food and Drug Administration (FDA) is anticipated to invest approximately $2 billion in evaluating New Drug Applications (NDAs), Biologics License Applications (BLAs), and Investigational New Drug applications (INDs), all submitted in the electronic Common Technical Document (eCTD) format. While electronic submissions have streamlined processes, concerns about data integrity persist due to the modifiable nature of digital files…