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Executive Summary

FDA's Office of Generic Drugs has identified as one of its highest priorities the formalization of the "first-in-first-reviewed" policy for ANDA applications. The "first-in-first-reviewed" initiative is one of 10 "priorities" listed in a Jan. 31 memorandum from Office of Generic Drugs Acting Director D. Bruce Burlington, MD, to Center for Drug Evaluation and Research Director Carl Peck, MD. The Office of Generic Drugs is "formalizing and implementing our 'first-in-first-reviewed' policy and system for new applications assignment to chemistry reviewers," the memo notes. Also, the office is creating a policy that will "identify exceptions to the 'first-in-first-reviewed' policy so that, where appropriate, selected amendments and supplements can be reviewed on an expedited basis." Accordingly, the office will communicate to sponsors "what constitutes major versus minor amendments" so they will know which ones will be "reviewed immediately and which will not be taken out of the queue," the memo adds. Burlington said that he considers the recommendations to be "high priority" and that "most are within the scope of the Office of Generic Drugs to accomplish over the next six months without major involvement of other parts of FDA." The recommendations were generated from unsolicited suggestions made by industry, academe, and different parties within the government on ways to improve the generic drug review process. The memo says that the recommendations have been discussed at three meetings involving the office and CDER staff. A notice requesting suggestions on how to improve the generic drug program, including review, compliance and regulatory matters, will be published in the Federal Register in "the next two weeks," the memo adds. The priority list also includes: "developing a policy to deal with economically motivated challenges to applications or bioequivalence standards by innovators and others; developing a systematic approach to apportion review resources to both supplements and original applications; recruiting highly qualified chemistry, labeling and pharmacokinetic reviewers, as well as support staff; developing and implementing programs for initial and ongoing training and career development for review staff; developing a policy on whether to file incomplete or segmental submissions of original and supplemental applications; defining an interim policy on biobatch size requirements and developing an approach to define a definitive policy; and identifying uniform points in the review cycle to request submission of validation samples and to request c-GMP certification so that these may be obtained in a timely and consistent matter." According to FDA, there are other recommendations under consideration that would require agency-wide coordination to implement.

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