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DRUG MASTER FILE APPROVAL SYSTEM WILL BE CONSIDERED IN FUTURE FDA WORKSHOP

Executive Summary

DRUG MASTER FILE APPROVAL SYSTEM WILL BE CONSIDERED IN FUTURE FDA WORKSHOP, Center for Drug Evaluation & Research Associate Director for Science and Medical Affairs Roger Williams, MD, told the Parenteral Drug Association/FDA Joint Conference in Bethesda, Md. Sept. 28. The workshop will be held "sometime this year," Williams said. FDA has been working to improve the drug master file (DMF) system in general. Williams said that "the part receiving the most attention right now is this proposal that DMFs somehow be approved." He commented that "that is a tricky question and we intend to discuss that issue in some kind of public forum." The proposal to approve DMFS, specifically Type II DMFs, is included among other options for reviewing DMFs in a report entitled "Recommendations for Improvement in FDA's Drug Master File System" completed in May. The report, prepared by CDER's Chemistry, Manufacturing, Controls Coordinating Committee, which is co-chaired by Williams, has been circulating among industry associations for comment. The report states that approval of DMFs would assure that the file is thoroughly examined. "Once a DMF is approved, it can be referenced without any fear that it will be found to be deficient," the report notes. In addition, DMF approval would eliminate the need for re-review, the report maintains. Some of the negative aspects of an approval system for DMFS, the report states, are that "DMFs may be approvable for one use but not for another (e.g., drug substance used in tablet vs. parenteral)." The report notes that "this may be handled by making the approval conditional for a single type of use." Also, DMFs will need to be reviewed at the time of submission rather than when first referenced. Other options mentioned in the report include: no longer accepting DMFs; reviewing the file upon submission and conferring "acceptability" to the DMF holder; and continuing the present system of reviewing DMFs when they are referenced in a drug application. Williams remarked that "there are certain problems with approving DMFs but we haven't excluded the possibility entirely; we recognize that there may be some value to DMF approvals." The FDAer noted that if the agency goes ahead with the proposal, it may use different terminology to distinguish DMF approvals from product approvals. "We might use another buzzword and say it's certified or authorized." The report contains some 21 recommendations on ways of improving the DMF system. The recommendations include: limiting re-review of DMFs to certain cases; discontinuing acceptance of domestic Type I DMFs and transferring all foreign Type I DMFs to the Office of Regulatory Affairs; issuing a policy and procedure guide for DMF reviews; and developing a system for classifying some DMF information as non-confidential. The report also recommends computerization of the DMF system, something which FDA has been working on for the past two years.
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