DMFs in The United States
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
In United States there are 5 types of Drug Master file:
-
- Type I Manufacturing Site, Facilities, Operating Procedures and Personnel
-
- Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
-
- Type III Packaging Material
-
- Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
-
- Type V FDA Accepted Reference Information
Read more about this topic: Drug Master File
Famous quotes containing the words united states, united and/or states:
“The parallel between antifeminism and race prejudice is striking. The same underlying motives appear to be at work, namely fear, jealousy, feelings of insecurity, fear of economic competition, guilt feelings, and the like. Many of the leaders of the feminist movement in the nineteenth-century United States clearly understood the similarity of the motives at work in antifeminism and race discrimination and associated themselves with the anti slavery movement.”
—Ashley Montagu (b. 1905)
“I feel most at home in the United States, not because it is intrinsically a more interesting country, but because no one really belongs there any more than I do. We are all there together in its wholly excellent vacuum.”
—Wyndham Lewis (1882–1957)
“A little group of wilful men reflecting no opinion but their own have rendered the great Government of the United States helpless and contemptible.”
—Woodrow Wilson (1856–1924)