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Regulatory News In Brief

Grant funding available through FDA’s Orphan Products Office. The latest on CDRH’s whistleblower email surveillance investigation. More regulatory news.

FDA’s Office of Orphan Products Development announces Aug. 6 the availability of grant funds. The goal of the program is to support the clinical development of devices, drugs, biologics and medical foods for use by patients with rare diseases or conditions where no current therapy exists or where the proposed product will be superior to existing therapy. Of the $14.1 million FY 2014 funding, approximately $10 million will fund non-competing continuation awards, and $4.1 million will fund 5 to 10 new awards, subject to the availability of funds. Phase I studies are eligible for grants up for $200,000 per year for up to three years, while phase II and III studies are eligible for up to $400,000 for up to four years. Application due dates are Feb. 6, 2013, and Feb. 4, 2014, and resubmission dates are Oct. 15, 2013, and Oct. 15, 2014. The anticipated start dates are in November 2013 and November 2014.

FDA responded Aug. 6 to a letter sent by Sen. Chuck Grassley, R-Iowa, in January requesting additional information about the agency’s surveillance of emails from CDRH...

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