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FDA "APPROVAL" LETTERS TO MARK END OF REGULATORY REVIEW PERIOD

Executive Summary

FDA "APPROVAL" LETTERS TO MARK END OF REGULATORY REVIEW PERIOD for purposes of patent term restoration determinations is being proposed by the agency. In proposing implementing regs for Title II (patent term restoration) of the ANDA/patent restoration law, FDA said in a July 11 Federal Register notice: "A marketing application is 'approved' . . . only on the date FDA notifies the applicant in writing that the application is approved." The agency continued: "For example, for human drug products, an approval letter will be issued when the only conditions which must be met prior to marketing relate to minor editorial labeling deficiencies . . . and will signify approval of a marketing application; while an 'approvable' letter . . . (which requires the applicant to take further substantive actions to meet certain conditions or supply additional information prior to marketing) will not signify approval." To initiate the regulatory review period, FDA said that the proposal would use the date at which an application was "initially submitted." The term will be defined as the point at which an applicant submits enough information for FDA to begin a "substantive review," the agency said. FDA explained that "an NDA that lacks the required manufacturing/controls information to permit FDA review would not be 'initially submitted' under this proposal. On the other hand, if FDA has commenced substantive review of the NDA and simply requested additional information, the NDA would have been 'initially submitted.'" The agency proposed a policy of flexibility and case-by-case analysis for reviewing petitions that allege an applicant has not acted with due diligence in pursuing an application. FDA maintained that the approach to determining due diligence has been adopted in prior legal case law pertaining to patent issues. FDA listed eight specific factors it would take into account when making due diligence determinations, although the agency emphasized that they "merely illustrate the kinds of factors that FDA will consider in due diligence determinations." For example, FDA said that it "will consider whether an allegedly nondiligent applicant's delay in submitting clinical results to FDA was reasonable considering the usual amount of time applicant nees to analyze test results." Among the other factors FDA said are illustrative of the issues it will examine in due diligence determinations are: "compliance or failure to comply with FDA regulations"; "unavailability of any key person involved in the activities of the applicant during the regulatory review period"; "physical destruction of essential testing facilities or essential data"; "delay caused by financial considerations"; and "implementation or failure to implement ordinary and necessary measures to minimize delay." The comment period for the proposed reg closes on Oct. 9, 1986, FDA noted. The agency also pointed out that proposed regs implementing Title I of the law, the section addressing ANDAs, will be published in the Federal Register at a future time.
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