Print“The FDA notes that “regulatory science tools are essential to speed new safe and effective therapies to patients who need them.”
The U.S. Food and Drug Administration reiterated the importance of regulatory science in its recently released a draft document of strategic priorities for the next four years. The FDA has identified five cross-cutting strategic priorities and four core mission goals and objectives that will guide efforts to fulfill its mission to protect the public’s health.
The FDA is charged with making sure that products accounting for 20 cents of every dollar spent by Americans are safe and effective. These products include human and animal drugs, 80 percent of the food supply, biological products, medical devices, cosmetics, and radiation-emitting products. It also regulates tobacco products using a population health standard.
Advancing regulatory science to keep regulators abreast of rapid advances in research and cutting-edge technologies topped the list of five cross-cutting strategic priorities for the next four years, followed by globalization, safety and quality, smart regulation, and stewardship. The FDA defines regulatory science as “the science of developing new tools, standards, and approaches to assess the safety, efficacy quality, toxicity, public health impact, or performance of FDA regulated products.”
Advancing regulatory science topped the FDA’s previous strategic priorities list and in 2011 the agency released a strategic plan for tackling regulatory science to improve the product development process that included increasing the quality and efficiency of clinical trials.
The FDA notes that “regulatory science tools are essential to speed new safe and effective therapies to patients who need them.
Globalization is also at the top of the FDA’s list of strategic priorities for the next four years as about more and more of FDA-regulated products come from other countries. The FDA says it is developing and international operating model that will be based on four pillars: sharing information; data-driven risk analytics; enhanced intelligence; and the smart allocation of resources through partnerships. The FDA says it is putting together a global coalition of regulators to increase the exchange of information.
The agency’s core mission goals and objectives include enhancing oversight of FDA-regulated products; improving and safeguarding access to FDA-regulated products to benefit health; promoting better informed decisions about the use of FDA-regulated products, and strengthening organizational excellence and accountability.
The agency’s strategic plan is open to public comment until the end of July.
July 06, 2014
http://www.burrillreport.com/article-advancing_regulatory_science_top_of_mind_at_fda_.html
