"Insufficient Data" Linked To Most NDI Notification Failures At FDA
This article was originally published in The Tan Sheet
Executive Summary
FDA rejects nearly 75% of new dietary ingredient notifications, with failure to provide sufficient ingredient identity or supporting data the most common reasons for rejection, says American Herbal Products Association President Michael McGuffin.
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FDA Budget In Brief
Drug program proposal: FDA requests $1 billion in fiscal 2011 funding for its human drug program, a 13.6 percent increase from the prior-year appropriation, more than half of which would be covered by user fees. The figure presented Feb. 1 in the Obama administration's proposed budget includes $849.7 million for activities within the Center for Drug Evaluation and Research, and $150.5 million for Office of Regulatory Affairs field operations. The agency seeks $446.5 million for new drug review functions across both CDER and ORA. One area of ORA's domestic program - the OTC monograph project and health fraud project inspections - seeks $95 million for fiscal 2011, which would match the 2010 estimate. Of the $1 billion total for drug activities, $516 million is projected to come from user fees - largely those existing under the Prescription Drug User Fee Act. However, $34.4 million in new generic drug user fees and $2.5 million in field re-inspection user fees are proposed for fiscal 2011. The user fee component would represent 51.6 percent of total drug program funding in fiscal 2011, up from 47.2 percent of the 2010 appropriation