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Executive Summary

NDA REFUSE-TO-FILE DECISIONS WILL BE REVIEWED by high-level officials of the Center for Drug Evaluation & Research as part of an expanded plan for internal oversight. FDA plans to explain the review process in an upcoming Federal Register notice. Previously, FDA had intended to spot-check a selection of refusal-to-file decisions. Under the plan to be announced soon, the agency will commit to review all of the refuse-to-file decisions. The FDA reviews will be conducted by the refuse-to-file committee, comprising all high level CDER officials, a Center for Biologics Evaluation & Research representative and FDA Chief Mediator and Ombudsman Amanda Pedersen. The committee recently voted to expand its schedule of quarterly meetings to bimonthly meetings to handle the new workload. The committee is concerned about the impact a potential incorrect decision not to file an application would have in the new era of user fees. FDA issued refuse-to-file guidances for NDAs and PLAs along with other user fee guidances in July ("The Pink Sheet" July 26, p. 4) Since the beginning of FDA's fiscal year in October, only one of the 22 applications submitted for a new molecular entity has been refused filing, CDER Acting Director Gerald Meyer reported in mid-November ("The Pink Sheet" Nov. 22, In Brief). He also reported that all refuse-to-file actions are down 19% from an average of 25% of NDA filings.

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