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# FDA Sees 2015-16 Regulatory Science Progress
- URL: https://www.fdaweb.com/fda-sees-2015-16-regulatory-science-progress/
- Published: 2017-03-30T12:00:00.000Z
- Updated: 2026-09-14T22:14:58.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5138337

The FDA 2016-16 Regulatory Science Progress Report, required under the FDA Safety and Innovation Act, cites gains it says it has made in a number of areas: 

- **Advancing the Science of Medical Product Development and Evaluation** through development of computational tools supporting nonclinical evaluation of medical products;
- **Improving Clinical Evaluation** through statistical assistance in designing trials of antibiotics that could evaluate factors related to development of resistant organisms;
- **Advancing Product Manufacturing and Quality** by developing in-house laboratory and computational capability for studying continuous manufacturing with an advanced process control system;
- **Ensuring the Safety and Effectiveness of Marketed Medical Products** through expansion of the Sentinel system and work to develop a national evaluation system for health technology;
- **Advancing Regulatory Science to Promote Global Health** through development of tools, reference materials, and publication of science-based guidance to support rapid development of new medical products to diagnose, treat, or prevent diseases caused by pathogens such as Ebola and Zika; and
- **Infrastructure Development and Organizational Changes to Advance Regulatory Science** through enhancing information technology tools that support scientific review of regulatory applications.