Sunday, October 24, 2010

Strategic Plan Published

FDA recently published their draft document outlining their Strategic Priorities for 2011 to 2015. Information technology will play an important role as FDA plans to implement an IT modernization program to support present and future state-of-the-art networked information and also to share data resources.

FDA plans to develop modernized data centers to support their IT needs. These data centers will provide for high performance and data storage needed today but they will also be designed to accommodate growth.

Specific goals are to:

• Partner with programs and industry to provide innovative IT to make it possible to collaborate across government and globally
• Maintain a secure environment where security, privacy, and confidentiality are addressed
• Manage IT projects and investments in order to demonstrate progressive incremental improvements

In the public health area, FDA’s key priority is to advance the safety and effectiveness of medical products. To do this, FDA is working to develop a new generation of information collection and analysis methods to fully understand real-world health outcomes resulting from medical products.

The report discusses how advances in science and technology show great promise for the development of new safe and effective biological products and relevant scientific discoveries. These include newly identified clinical biomarkers, adaptive clinical trial designs, and genomics but will also require new regulatory guidance documents for industry. To meet this need, FDA is working on improving connectivity of agency databases and how to simplify storage procedures.

The FDA’s National Center for Toxicological Research is researching new computational approaches and technologies to use to evaluate human health outcomes, as well as to find new methods to identify, quantify, and characterize potential microbial and chemical contaminants in foods and other FDA-regulated products.

In addition, FDA is planning a series of workshops to address important and difficult rare disease research issues and developing a rare disease database to establish the natural history of rare diseases to assist with planning trials that will be able to test rare disease therapies.

To download the draft of the report, go to