FDA outlines goals, strategy

Improving animal models to consider the influence of disease progression, increasing the efficiency of clinical trials, and increasing access to government-collected clinical data are among the dozens of goals described in a strategy plan published by the Food and Drug Administration.

The agency published in August its Strategic Plan for Regulatory Science, which is intended to direct agency actions to improve the drug and medical device approval processes, increase food safety, and give health care providers increased access to information. The plan indicates that available resources will be used both within the FDA and to work with private and public partners to achieve the plan's goals.

Vicki Seyfert-Margolis, PhD, senior adviser for science innovation and policy for the FDA Commissioner's Office, said in an agency podcast that the FDA plan is intended to improve the process from basic research to delivery of new medical products. The changes should help patients through development of the next generation of medical products, she said.

Such products include innovations arising from research on the human genome, products developed through the use of nanotechnology, and increasingly complex biologics, she said.

The FDA plan also calls for the agency to encourage innovation in personalized medicine and to help people and professionals in health care make informed decisions about regulated products.

The plan is available at www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/.