FDA/NIH program supports regulatory innovations
This article was originally published in The Tan Sheet
Executive Summary
FDA and the National Institutes of Health launch a grant program to upgrade FDA's regulatory science, seeking proposals from academic institutions or non-profits interested in developing innovative approaches for reviewing applications for new medical products - including drugs, biologics and devices - and new ways of monitoring product safety and manufacturing processes. The program, announced Feb. 24, is FDA Commissioner Margaret Hamburg's latest effort to upgrade the agency's capacity to evaluate drug and device development programs. Existing agency budgets will fund the three-year, $6.75 million program, with 89 percent from NIH. The Obama administration requested $25 million to improve regulatory science capacity at FDA for fiscal 2011