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EXCIPIENT DRUG MASTER FILE

This article was originally published in The Gold Sheet

Executive Summary

...reform efforts may open the door to new pharmaceutical inactive ingredients. In discussions between FDA and industry on the DMF process, the concept of a third-party review of new excipients has been gaining momentum. International harmonization and electronic formatting are also being targeted to improve the DMF component of the drug approval process. Monograph harmonization continues as USP seeks to shore up its part of the excipient regulatory framework. Industry is developing guidances specific to excipient and packaging master files to help fill a gap in agency instructions.
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