Open AccessDMF FILING IN US, EUROPE AND CANADA
Author(s) -
Pooja Agarwal,
J. K. Badjatya
Publication year - 2018
Publication title -
international journal of drug regulatory affairs
Language(s) - English
Resource type - Journals
eISSN - 2321-7162
pISSN - 2321-6794
DOI - 10.22270/ijdra.v3i4.172
Subject(s) - confidentiality , drug , discretion , business , product (mathematics) , process (computing) , computer science , internet privacy , database , law , computer security , political science , pharmacology , medicine , operating system , geometry , mathematics
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.