Preferred Label : Drug Master File;
NCIt related terms : DMF; Master File; Drug Master File (DMF);
NCIt definition : 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.;
Alternative definition : FDA: 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.; PQCMC: Drug master files (DMFs) are submissions to FDA used to provide confidential,
detailed information about facilities, processes, or articles used in the manufacturing,
processing, packaging, and storing of human drug products. They 1) Allow parties to
reference material without disclosing DMF contents to those parties. 2) Are not required
by statute or regulation. 3) Are neither approved nor disapproved. Instead, FDA reviews
the technical contents of DMFs in connection with the review of applications that
reference them (e.g., NDAs, ANDAs, INDs, BLAs).;
Origin ID : C70877;
UMLS CUI : C2348345;
Automatic exact mappings (from CISMeF team)
- Semantic type(s)
- concept_is_in_subset
