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U.S. Department of Health and Human Services

Drugs

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The Need for JumpStart

The development of JumpStart was driven by the following needs:

  • To manage applications growing in number and complexity
  • To implement standardized clinical trial data for analyses

 

Managing Applications Growing in Number and Complexity

Over the last several years, sponsors have submitted electronic New Drug Applications (NDAs) and Biologic License Applications (BLAs) to the FDA in greater volumes, and applications have grown in complexity as regulatory science evolves.

As the workload at CDER continues to increase, the use of standardized data, tools intended to perform analyses on standardized data, and supportive services become critical to the effective management and completion of NDA and BLA reviews.

CDER’s Office of Computational Science is developing ways to manage the increase of applications and created JumpStart as part of this initiative.

 

Implementing Standardized Data for Analyses

The FDA houses the largest known repository of clinical trial data, including unique high-quality data on the safety, effectiveness, and performance of drugs and biologics, both pre- and post-approval. When these data are not collected or stored in a standardized format, it is difficult to perform various required analyses during the scientific regulatory review process.

In 2010, the CDER Data Standards Program was established “to identify and prioritize data standards needs and to implement good practices for standards development.” As more clinical trial data are being submitted in a standardized format, JumpStart was designed to accommodate these data submissions by providing the appropriate tools and services to quickly and efficiently run analyses.

 

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