Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market. There is no regulatory requirement to file a DMF. However, the document provides the regulatory authority with confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Typically, a DMF is filed when two or more firms work in partnership on developing or manufacturing a drug product. The DMF filing allows a firm to protect its intellectual property from its partner while complying with regulatory requirements for disclosure of processing details.
Read more about Drug Master File: Description, DMFs in The United States, DMFs in Europe
Famous quotes containing the words drug, master and/or file:
“Upon entering my vein, the drug would start a warm edge that would surge along until the brain consumed it in a gentle explosion. It began in the back of the neck and rose rapidly until I felt such pleasure that the world sympathizing took on a soft, lofty appeal.”
—Gus Van Sant, U.S. screenwriter and director, and Dan Yost. Bob Hughes (Matt Dillon)
“Now we sing, and do tiny dances on the kitchen floor.
Our whole body is like a harbor at dawn;
We know that our master has left us for the day.”
—Robert Bly (b. 1926)
“While waiting to get married, several forms of employment were acceptable. Teaching kindergarten was for those girls who stayed in school four years. The rest were secretaries, typists, file clerks, or receptionists in insurance firms or banks, preferably those owned or run by the family, but respectable enough if the boss was an upstanding Christian member of the community.”
—Barbara Howar (b. 1934)