Definition · Plain-language
New Drug Application (NDA)
A New Drug Application (NDA) is the formal request to the FDA for approval to market a new drug in the United States, submitted under the Federal Food, Drug, and Cosmetic Act.
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What an NDA is for
The New Drug Application is the vehicle by which a sponsor formally asks the FDA to approve a new drug — typically a small-molecule pharmaceutical — for sale and marketing in the United States. It is the culmination of the drug-development process: after years of laboratory and clinical study conducted under an Investigational New Drug application, the accumulated evidence is assembled into the NDA. The goal of the application is to provide enough information for FDA reviewers to determine whether the drug is safe and effective for its proposed use, whether its benefits outweigh its risks, and whether the proposed labelling is appropriate.
The 505(b)(1) and 505(b)(2) routes
NDAs are submitted under section 505 of the Federal Food, Drug, and Cosmetic Act. A 505(b)(1) application is a full application containing complete reports of investigations of safety and effectiveness conducted or sponsored by the applicant. A 505(b)(2) application may rely in part on data the applicant did not generate — for example published literature or the FDA’s prior findings for an approved drug — and is often used for modifications such as a new dosage form. Generic copies of approved drugs instead use the separate Abbreviated New Drug Application (ANDA) pathway under 505(j).
What the application contains
An NDA must include the results of non-clinical (animal) and clinical (human) studies, information on the drug’s pharmacology and toxicology, chemistry, manufacturing and controls describing how the drug is made and tested, proposed labelling, and any patent and exclusivity information. CDER assesses whether the data support approval and whether the manufacturing methods preserve the drug’s identity, strength, quality and purity. Approval permits interstate marketing; the FDA can also require post-marketing studies and a risk management plan.
Key facts
At a glance
- Definition: Application to market a new drug in the United States.
- Stands for: New Drug Application.
- Statute: Federal Food, Drug, and Cosmetic Act, section 505.
- Standard: Drug must be shown safe and effective for its intended use.
- Routes: 505(b)(1) full application; 505(b)(2) relies partly on others’ data.
- Reviewer: FDA — Center for Drug Evaluation and Research (CDER).
Common misconceptions
What people often get wrong
Often heard: Generic drugs are approved through a New Drug Application.
Actually: Generics use the Abbreviated New Drug Application (ANDA) pathway under section 505(j), which relies on showing bioequivalence to an approved reference drug rather than repeating full safety and effectiveness studies.
Often heard: An NDA is used to market biological products such as vaccines.
Actually: Biological products are licensed through a Biologics License Application under the Public Health Service Act. The NDA, under the Federal Food, Drug, and Cosmetic Act, is for drugs — typically small molecules.
Often heard: A 505(b)(2) application means the drug was not properly tested.
Actually: A 505(b)(2) application is a legitimate full-approval route that may rely partly on data the applicant did not generate, such as published literature, while still requiring the FDA to find the drug safe and effective.
