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NDA REVIEW-PLANNING MEETING WITHIN 45 DAYS OF FILING

Executive Summary

NDA REVIEW-PLANNING MEETING WITHIN 45 DAYS OF FILING is being called for by the Center for Drug Evaluation & Research to make NDA reviews more timely and consistent. The initiative is one of five immediate review strategies developed by CDER management during a recent two-day retreat ("The Pink Sheet" Oct. 14, p. 14). An attachment to an Oct. 17 memorandum sent to all CDER staff lists the five initiatives: (1) "An internal planning meeting within 45 days of NDA receipt to establish NDA review team assignments, plan, timetable and fileability; (2) consistent policy on NDA fileability; (3) managed concurrent primary/secondary NDA reviews; (4) timely determination of labeling to expedite NDA approval actions; and (5) development of guideline for the structure and content of the primary NDA reviews." The initiatives represent a more extensive and structured planning process for NDA reviews than that which has occurred in the past, FDA said. The meetings are expected to encourage reviewers of an NDA to coordinate their reviews. In these meetings, reviewers will forecast when they will be finished with their reviews, when interim reports on their reviews will be due, when an advisory committee meeting should be scheduled and whether allocation of review work needs to be shifted. FDA pointed out that such a structured review process already has been used in the review of Bristol-Myers Squibb's Videx (ddI). Videx was approved on Oct. 9 after a landmark effort by FDA reviewers to expedite the review by gleaning additional evidence of the drug's efficacy from ongoing trials. The agency plans to establish a committee to develop a single standard for determining the requirements for NDA submissions that will be used consistently in each drug review division. One initiative calls for the primary reviewer and the secondary reviewer to review an NDA concurrently. In the past, the primary examiner first conducted the review and then the secondary reviewer completed the process. CDER will also develop a guideline on how to structure the review of the clinical and statistical sections of NDAs and how to write a report of the review.
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