New Drug Application
New Drug Application (NDA)
New Drug Application (NDA) /ˈnjuː drʌɡ æplɪˈkeɪʃən/ is a regulatory step taken by a pharmaceutical company requesting the Food and Drug Administration (FDA) to consider a drug for marketing approval.
Etymology
The term "New Drug Application" is specific to the United States and comes from the regulatory process established by the Food, Drug, and Cosmetic Act of 1938 and subsequent amendments. The term reflects the application's purpose: to propose a new drug to the market.
Definition
A New Drug Application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
Related Terms
- Investigational New Drug (IND): An IND is a pharmaceutical drug that has been approved by the U.S. FDA for use in clinical trials on humans. Before a drug can be tested on humans, the pharmaceutical company or other sponsor must submit an IND application to the FDA.
- Food and Drug Administration (FDA): The FDA is a federal agency of the United States Department of Health and Human Services, responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, animal foods & feed, and veterinary products.
- Food, Drug, and Cosmetic Act: The United States federal law that gives authority to the FDA to oversee the safety of food, drugs, medical devices, and cosmetics.
External links
- Medical encyclopedia article on New Drug Application
- Wikipedia's article - New Drug Application
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