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:
“He’d been numb a long time, years. All his nights down Ninsei, his nights with Linda, numb in bed and numb at the cold sweating center of every drug deal. But now he’d found this warm thing, this chip of murder. Meat, some part of him said. It’s the meat talking, ignore it.”
—William Gibson (b. 1948)
“He’s the master of the nightmare. He’s the Gustave Doré of the world of Henry Ford and Co., Inc.”
—Henry Miller (1891–1980)
“A common and natural result of an undue respect for law is, that you may see a file of soldiers, colonel, captain, corporal, privates, powder-monkeys, and all, marching in admirable order over hill and dale to the wars, against their wills, ay, against their common sense and consciences, which makes it very steep marching indeed, and produces a palpitation of the heart.”
—Henry David Thoreau (1817–1862)