FDA Issues Draft Guidance for Generic-Drug Review Process

The US Food and Drug Administration (FDA) has issued two draft guidance documents for improving the generic drug review process when submitting abbreviated new drug applications (ANDAs).

The first draft guidance, ANDA Submissions – Refuse-to-Receive Standards: Questions and Answers, is an updated, question and answer-inclusive version of an earlier guidance, ANDA Submissions—Refuse-to-Receive Standard, which was finalized in September 2014, to assist applicants preparing to submit to the FDA ANDAs and certain prior approval supplements (PASs) to ANDAs. A refuse-to-receive (RTR) decision indicates that the FDA has determined that an ANDA is not a substantially complete application. The updated questions-and-answers draft guidance addresses general issues about the organization of an ANDA, filing decisions made by FDA, the review of and deficiencies related to drug master files, product quality, and bioequivalence and clinical reviews, and are intended to clarify the deficiencies that may cause the FDA to refuse to receive (RTR) an ANDA.

The second draft guidance, ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA, explains to applicants how the review goals established as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) apply to amendments to either ANDAs or PASs submitted to the FDA. The guidance describes amendment classifications and categories and explains how amendment submissions may affect an application’s review goal dates. The guidance also describes how the FDA should review amendments submitted to ANDAs and PASs received prior to October 1, 2017, which is the GDUFA II review goals effective date.

GDUFA II simplified the amendment review goals and no longer subjects them to a tier system; however, GDUFA II review goals are still dependent on several factors. In general, GDUFA II amendments will be designated as either standard or priority, be classified as either major or minor, and receive a goal date based on the factors discussed in the guidance, including whether a preapproval inspection is needed.

Source: FDA (RTR standards) and FDA (amendments to ANDAs)


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