September 23, 2019Regulatory
This article is fully compatible with what we observed in the DPharm Disruptive Innovations meeting in Boston last week.
Recent scientific and biomedical advances - from genomic sequencing to development of cell and gene therapies and nanotechnologies - have brought the promise of significant improvements to the health of many millions of Americans. To date, however, most have seen little of this promise in our day-to-day lives because a large and persistent gap separates important scientific advances and the technologies needed to translate those advances into new therapies for patients and new ways to protect the public health. The FDA's FDA's Technology Modernization Action Plan, described in this document, is an important step FDA is taking to address and close this gap. It describes important near-term actions that FDA is taking to modernize use of technology - computer hardware, software, data, and analytics - to advance FDA's public health mission.
TMAP has three elements:
1. modernization of FDA's technical infrastructure;
2. enhancing FDA's capabilities to develop technology products to support its regulatory mission; and
3. communication and collaboration with stakeholders to drive technological progress that is interoperable across the system and delivers value to consumers and patients.
The TMAP provides a sturdy technological foundation for development of FDA's ongoing strategy around data itself - a strategy for the stewardship, security, quality control, analysis, and real-time use of data - that will accelerate the path to better therapeutic and diagnostic options for patients and clinical care providers, and better tools to enhance and promote public health.