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 derived from the regulatory process in the United States where a 'new drug' is an active ingredient or combination of ingredients that has not been previously marketed in the United States in a legally marketed drug product.
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 study 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 FDA for use in clinical trials on humans, but has not yet been approved for sale in the marketplace.
- 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.
- Clinical Trials: Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison.
External links
- Medical encyclopedia article on New drug application
- Wikipedia's article - New drug application
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