Recent news
August 2011
FDA releases plan for regulatory science
August 24, 2011 -- The US Food and Drug Administration (FDA) recently released a “Strategic Plan for Regulatory Science,” calling for a modernization of the science used in developing and evaluating health and food products. The strategic plan describes the agency’s intent to enhance the process for developing and evaluating promising new products and novel materials from fields such as cell therapy, tissue engineering, genomics, personalized medicine, advanced computing, and information technology.
"The core responsibility of FDA is to protect consumers by applying the best possible science to its regulatory activities—from pre-market review of efficacy and safety to post-marketing product surveillance to review of product quality,” the strategic plan reads. It adds, "In the last few years, rapid advances in innovative science have provided new technologies to discover, manufacture, and assess novel medical products. FDA must both keep pace with and utilize these new scientific advances in order to accomplish its mission to protect and promote the health of our nation."
According to FDA Commissioner Margaret Hamburg, the “breadth and scope of FDA’s regulatory oversight is extraordinary, touching the lives of every American, through the food they eat, the medicines they take, and the medical devices they use.” She added, “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.” See the links below for more details.
