New Drug Application

New Drug Application (NDA) is a type of application in which a pharmaceutical manufacturer or its agent requests permission from the U.S. Food and Drug Administration (FDA) for a license to market a drug for one or more specified indications. In addition to a chemical and pharmacologic description of the drug, an NDA must show the results of clinical trials conducted with respect to the indication for which a license is requested.

Whereas a NDA is used for drugs subject to the drug approval provisions of the United States Federal Food, Drug, and Cosmetic (FD&C) Act, a biologics license application (BLA) is required for biological products (biologics) subject to licensure under the Public Health Service (PHS) Act.

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U.S. Food and Drug Administration (FDA): Frequently Asked Questions About Therapeutic Biological Products
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NCATS Toolkit for Patient-Focused Therapy Development: FDA Review and Approval
U.S. Food and Drug Administration (FDA): New Drug Application (NDA)

Synonyms:
NDA
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