DMF Guidelines Get Agency Comment


FDA's Arthur Shaw, PhD, has provided written comments on a proposal submitted to the agency by the Type III Drug Master File (DMF) Subcommittee in May 2002. "Proposed Guidelines for the Content of Type III Drug Master Files" discusses the content of a Type III DMF used primarily as a reference document for the DMF holder's confidential or proprietary information in support of applications for drugs and biologics. It is the product of a group of drug industry professionals, packaging component suppliers, academicians, and drug law attorneys.

According to Hugh Lockhart, PhD, professor of the School of Packaging at Michigan State Uni-versity and a coauthor of the proposal, all of the comments are "supportive of the document as we prepared it, with some relatively minor changes." Lockhart served as chair of the National DMF Workshop, which was held March 25–27, 2002, in Arlington, VA, where the proposal served as a discussion paper.

FDA comments on the guideline proposal were provided by Shaw, a chemist in FDA's Office of Pharmaceutical Science at the Center for Drug Evaluation and Research. Shaw is widely recognized in the industry for his long experience and expertise in guidance relevant to drug master files, says Lockhart. Shaw added to the proposal's section outlining the responsibility for providing packaging component information to FDA directly in the drug product application or in a DMF. "The amount of information provided in the DMF is also dependent on how much information is provided by the applicant," he wrote. "For instance, a DMF holder may provide extraction data under a number of standard conditions. However, the applicant may need to provide additional product-specific extraction data." Shaw also clarified one aspect of the letter of authorization, the written statement by the DMF holder that authorizes FDA to refer to information in the DMF in support of a regulatory application. "For DMFs that contain different items, the letter of authorization should be restricted only to the item of interest," wrote Shaw.

He endorsed a spirit of cooperation between DMF holders and applicants by describing that the DMF holder should request that the applicant provide the name of a contact person when a DMF holder receives a request for a letter of authorization from an applicant. Shaw further clarified the proposal's statement that the agency will notify the applicant when it has found a deficiency in a DMF. He writes that "the details and nature of the deficiency will not be revealed to the applicant, unless the DMF holder specifically authorizes release by FDA of that information to the applicant." Further, Shaw commented that "if a DMF holder responds to deficiencies by providing the information to the applicant to be included in the application, the same information should be provided to the DMF."

According to Shaw, "these are FDA's informal comments and do not imply endorsement of the statements in the guideline as official FDA policy, unless they are the same as those found in official FDA guidances." The Type III DMF Subcommittee has reviewed the comments and is revising the proposal to reflect the issues noted by Shaw. Revision 2 of the proposed guidelines will then be posted on the DMF Web site, "It is the goal of the Type III DMF Subcommittee to provide the most accurate and useful guide possible for use in preparation of drug master files," Lockhart says.

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