What is New Drug Application (NDA), Investigational New Drug (IND), and Abbreviated New Drug Application (ANDA)?

New Drug Application (NDA), Investigational New Drug (IND), Abbreviated New Drug Application (ANDA)

The New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.

The investigational new drug (IND) application is the result of a successful preclinical development program. The IND is also the vehicle through which a sponsor advances to the next stage of drug development known as clinical trials (human trials).

An Abbreviated New Drug Application (ANDA) contains data submitted to FDA’s Center for Drug Evaluation and Research, Office of Generic Drugs, for review and ultimate approval of a generic drug product.



Also read: Regulatory authorities and agencies

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