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FDA PRE-APPROVAL INSPECTIONS: "PLANT NOT CAPABLE" IS MOST FREQUENT REASON

Executive Summary

FDA PRE-APPROVAL INSPECTIONS: "PLANT NOT CAPABLE" IS MOST FREQUENT REASON for NDA turndowns during the past year, according to data compiled by FDA field management. During the third year of the pre-approval inspection program (March 1992 through February 1993), agency field offices recommended withholding approval of 36 NDAs for listing plants not capable or ready to perform as indicated on the application. The finding accounted for almost one-third of the 131 recommendations to withhold NDAs by the FDA districts for the year. "Numerous GMP problems" was the most common reason for recommendations to withhold ANDAs during the past year, accounting for 50 of 236 turndowns (22%), according to the FDA field office analysis. Numerous good manufacturing practice problems were the second leading cause of withholding NDAs; 26 NDA approval turndowns (20%) resulted from inspection findings of widespread GMP non-compliance. The new data on FDA's pre-approval inspection program was presented by Mid-Atlantic Region Assistant Director Joseph Phillips at a University of Georgia (Athens) conference on GMPs in mid March. Phillips reported that the overall rate of district office turndowns following pre-approval inspections remained relatively constant from the previous year; 37% of applications failed to clear inspections in the year ending March 1993, compared to 36% the previous year. Excluding supplements, exactly half of ANDAs and 43% of NDAs evaluated failed to clear pre-approval review by the FDA district offices. Only about one in five supplements were not cleared by the districts. The percentage of applications for which inspections were conducted by the district offices rose slightly to 72% from 70% the previous year. However, if supplemental applications were removed from the aggregate data, that percentage would have been considerably higher. Supplements, which are not as likely to draw an inspection from the field offices, comprised about 30% of the evaluations performed by the district offices during the year. Regulatory actions pending against the applicant or a listed supplier, a particular problem in the ANDA context, was the third most frequent cause of approval delay recommendations overall during the past year, accounting for 53 NDA/ANDA turndowns. Findings of significant problems with test methods, stability programs, and product development were other frequent causes for turndowns.
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