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New Drug Application (NDA)
Practical Law Glossary Item 4-543-2445 (Approx. 3 pages)
Glossary
New Drug Application (NDA)
A federal application to market a new drug in the US under Section 505(b) of the Food, Drug, and Cosmetic Act (21 U.S.C. § 355(b)). The new drug application (NDA) must include:
- A full description of the drug's components and how the drug behaves in the body.
- The results of animal studies and human clinical trials.
- A full description of the facilities, methods, and controls used to manufacture and package the drug.
- The patent number and expiration date of any patent the applicant believes covers the drug or its proposed uses.
This information allows the Food and Drug Administration (FDA) to determine whether:
- The drug is safe and effective in all its proposed uses, and whether the drug's benefits outweigh the risks.
- The product labeling, including the package insert, is appropriate, and what it should contain.
- The manufacturing methods and controls will preserve the drug's identity, strength, quality, and purity.
The FDA has 60 days from its receipt of the NDA's submission to conduct a preliminary review and determine whether it is sufficiently complete so the FDA can accept it for a substantive review. Generally, the FDA conducts its substantive review and issues an action letter within ten months after accepting an NDA for standard review, and within six months for priority review. The FDA's substantive review of the NDA can take longer, with multiple review cycles, if the sponsor submits additional information to address deficiencies.