Difference between revisions of "Drug Master File"
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A Drug Master File (DMF) is a submission to the Food and Drug Administration ([[FDA]]) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. 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, an Export Application, or amendments and supplements to any of these. | A Drug Master File (DMF) is a submission to the Food and Drug Administration ([[FDA]]) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. 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, an Export Application, or amendments and supplements to any of these. | ||
| − | A DMF is NOT a substitute for an [[IND]], [[NDA]], [[ANDA]], or [[Export Application]]. It is not approved or disapproved. Technical contents of a DMF are reviewed only in connection with the review of an [[IND]], [[NDA]], [[ANDA]], or [[Export Application]]. ==External Links== | + | A DMF is NOT a substitute for an [[IND]], [[NDA]], [[ANDA]], or [[Export Application]]. It is not approved or disapproved. Technical contents of a DMF are reviewed only in connection with the review of an [[IND]], [[NDA]], [[ANDA]], or [[Export Application]]. |
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| + | ==External Links== | ||
[http://www.fda.gov/CDER/guidance/dmf.htm FDA Guideline For Drug Master Files] | [http://www.fda.gov/CDER/guidance/dmf.htm FDA Guideline For Drug Master Files] | ||
[[Category:RPS Glossary]] | [[Category:RPS Glossary]] | ||
Latest revision as of 14:58, 29 September 2008
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. 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, an Export Application, or amendments and supplements to any of these.
A DMF is NOT a substitute for an IND, NDA, ANDA, or Export Application. It is not approved or disapproved. Technical contents of a DMF are reviewed only in connection with the review of an IND, NDA, ANDA, or Export Application.
