FDA's Release of Strategic Plan for Regulatory Science
August 17, 2011
Dear International Colleague:
On August 17, the U.S. Food and Drug Administration released the Strategic Plan for Regulatory Science, calling for a sweeping modernization of the science used in developing and evaluating products critical to the nation’s health, economy and security. The plan provides specific details of the agency’s Regulatory Science Initiative, the framework of which was originally announced in October, 2010 (and is available at
The Strategic Plan signals the agency’s intention to enhance the process for developing and evaluating promising new products and novel materials emerging from fields such as cell therapies, tissue engineering, genomics and personalized medicine, and through use of advanced computing and information technology. Additionally, it underscores the agency’s emphasis on food safety through the priority of risk and efforts to enhance response and investigation efforts.
Furthermore, it reveals the agency’s intention to study and improve how it communicates health information to consumers, particularly as communication technologies rapidly evolve and change the way people receive important health information.
Additionally, the report explains how the agency will: facilitate the development of medical countermeasures to protect the U.S. against infectious diseases, chemical and nuclear threats; strengthen toxicology to better predict and prevent safety problems; support new approaches to product manufacturing and quality; and better access and analyze the vast amount of information the FDA collects to improve how products are used and to prevent or detect potential risks.
“The breadth and scope of FDA’s regulatory oversight is extraordinary, touching the lives of everyone who eats food, takes medicine or uses a medical device,” said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. “As new discoveries yield increasingly complex products, this strategic plan ensures that our experts are equipped to make science-based decisions resulting in sound regulatory policy. It positions us to foster innovation through better science without compromising our high safety standard.”
Please direct any questions or concerns to FDA’s Office of the Chief Scientist at 301-796-9600
Mary Lou Valdez, MSM
Associate Commissioner for International Programs