Regulatory Focus™ > News Articles > FDA to Put $2.5M Behind Kidney Initiative Meant to Optimize Drug Development

FDA to Put $2.5M Behind Kidney Initiative Meant to Optimize Drug Development

Posted 10 June 2014 | By Alexander Gaffney, RAC

FDA to Put $2.5M Behind Kidney Initiative Meant to Optimize Drug Development

US regulators say they're planning to award at least $500,000, and as much as $2.5 million, to a set of initiatives meant to improve the regulator's understanding of the effects of pharmaceutical products on the kidney.

In a Federal Register notice issued on 9 June 2014, FDA said its Center for Drug Evaluation and Research (CDER) plans to award a one-year, $500,000 contract to the American Society of Nephrology (ASN) to support the regulator's Kidney Health Initiative (KHI). The contract has four one-year extension options, each of which is worth $500,000 and depends on FDA's availability of funding.

The KHI was formed as a public-private partnership between FDA and ASN, a nonprofit whose goal is to advance research against kidney disease. FDA explained in its Register notice that KHI is intended to act as a "collaborative environment in which FDA and the greater nephrology community can interact to optimize evaluation of drugs, devices, biologics, and food products."

"KHI helps to effect change through the conduct of projects that address barriers to innovation, facilitate critical evidence generation, and/or elucidate safety concerns," FDA explains in the notice.

Noting the "significant value" the forum affords to regulators and their stated goals, the agency said a stream of grant money would further help KHI to maintain its scientific infrastructure, implement projects, hire staff, conduct research and generate project results.

 

Federal Register Notice


Categories: Regulatory News

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