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FDA NDA REWRITE FINAL RULE "DOUBLES" PAPERWORK FOR NDA APPLICANTS, PMA

Executive Summary

FDA NDA REWRITE FINAL RULE "DOUBLES" PAPERWORK FOR NDA APPLICANTS, PMA maintained in a recent letter to the Office of Management & Budget. The doubling of paperwork, PMA explained, occurs because "for each study, the applicant must develop a detailed tabulation of all the data on the case report forms. In addition, the case report forms must be submitted." PMA said that the NDA rewrite final rule differs from the 1982 proposal by requiring that data tabulations contain all the data contained in the case report forms, not just the data pertinent to safety and efficacy. "Tabulations should properly include data relevant to safety and efficacy considerations but not necessarily all data that may appear on the case report form." The requirement that all data appear in the tabulations, PMA asserted, "is excessive." In addition, PMA said that it "is concerned that the actual case report forms, from which the tabulations are developed, will be routinely submitted. The final regulation suggests that such forms will be needed for 'critical' studies and for other studies if requested by FDA. Critical is undefined and will be interpreted by some NDA reviewers to be virtually any study submitted in the NDA. We therefore question the FDA's estimate. . . that 46,900 hours will be saved by the elimination of routine submission of most case report forms." PMA addressed its comments on the NDA rewrite to OMB, which has the authority to review any FDA regulation procedure. PMA said that "we respectfully request that this excessive dual request be reviewed by the Office of Management and Budget and that FDA be asked to reconsider its determination. The FDA should modify the rule to be consistent with the 1982 proposal and the PMA's comments on that proposal."
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