DMF FILING IN US, EUROPE AND CANADA
A Drug Master File or DMF is a reference source that provides drug evaluator’s confidential information not available to drug product manufacturer about the specific process and components used in the manufacturing, processing and packaging of a drug meant for Human/Animal use. The submission of a DMF is not required by law or FDA regulation. A DMF is submitted solely at the discretion of the holder. The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, or amendments and supplements to any of these.
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6. Classifying resubmission of original NDAs, BLAs, and efficacy supplements in response to complete response letters. [Internet]. [Cited on 4 April 2013].
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http://www.gpo.gov/fdsys/pkg/FR-2013-08- 02/pdf/ 2013 -18625.pdf.
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10. Canada DMF fees [Internet]. Health Canada; 2013[cited 2015 Nov 03]. Available from:
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