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Biosecurity News in Brief
FDA Changes Process for Product Licensure NotificationBy Matthew Watson, July 11, 2008 On July 9, 2008, the U.S. Food and Drug Administration (FDA) issued a news release announcing a change in the format of letters that are sent to pharmaceutical companies to inform them of the FDA’s decision regarding licensure of pharmaceutical products.1 In the past, the FDA’s Center for Drug Evaluation and Research (CDER) sent one of three letters to applicants. An “approval” letter indicated that the product met agency standards and has been granted licensure for distribution in the U.S. If a company was not granted licensure for a candidate product, but only minor regulatory hurdles existed, FDA sent an “approvable” letter. Finally, if an application contained significant deficiencies, a “not approvable” letter was sent.1 The alteration to the process entails replacement of “approvable” and “not approvable” letters with a “complete response” letter. This new format informs pharmaceutical companies that the CDER has reviewed the candidate product and that the product has not been granted licensure, and it explains changes the company needs to make to the products to obtain licensure.1 Dr. Janet Woodcock, CDER’s director, explained the change and commented that "[t]hese new regulations will help the FDA adopt a more consistent and neutral way of conveying information to a company when we cannot approve a drug application in its present form…Thorough and timely review of drug applications is a priority of the FDA, and these new processes will make our communications with sponsors of applications more consistent."1 The new letter format will be used beginning on August 11, 2008.1 References
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