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Snow banks FDA's user fee deadlines

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Following the severe snowstorms in the D.C. area in early February, FDA is allowing for extensions to user fee goal dates. "As needed," FDA will extend PDUFA dates up to five business days for applications with goals that came due during the week of Feb. 8 or the week of Feb. 15, to adjust for the days that the agency was closed. For user fee goals due Feb. 22 and later, "FDA will assess the practicality of meeting the goal and will extend the goal as needed, but no more than the number of business days that the federal government and FDA buildings were closed," the agency said. However, FDA does not expect many applications to require an extension. The agency was able to send out at least one "complete response" letter Feb. 10 (for Cadence's I.V. acetaminophen), but took the full five day extension to issue a complete response on GSK/Xenoport's Horizant on Feb. 17; extreme weather did cause the postponement of a Feb. 10 meeting of the Oncologic Drugs Advisory Committee (1"The Pink Sheet," Feb. 22, 2010). Review deadlines could also be impacted for applications coming in to the agency during the snowstorm period
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