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New Drug Application (NDA)

A 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.[1]

The documentation required in an NDA is supposed to tell the drug's whole story, including what happened during the clinical tests, what the ingredients are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged.[2] The goal is to give FDA reviewers enough information to establish the complete history of the candidate drug.[3]

Before a drug can be tested on human subjects in the United States, its maker must first obtain an Investigational New Drug (IND) designation from the FDA.[4] Since the 1962 Kefauver–Harris Amendment, new drugs must show both safety and effectiveness through substantial evidence in order to be approved.[5] The data submitted must include results from one or more rigorous clinical trials.[4] The FDA has interpreted the statute as requiring at least two adequate and well-controlled clinical trials, each convincing on its own.[6] However, a 1997 amendment expressly lets the FDA consider other types of confirmatory evidence alongside one adequate and well-controlled clinical investigation.[6]

Once an application is submitted, the FDA has 60 days to carry out a preliminary review of whether it is sufficiently complete to permit a substantive review.[7] If the FDA finds it insufficiently complete, it rejects the application by sending a Refuse to File letter explaining where the requirements were not met.[7] A standard review implies an FDA decision within about 10 months, while a priority review should complete within 6 months.[8]

Why it matters to investors

The NDA is the formal step at which a sponsor asks the FDA to approve a new pharmaceutical for sale and marketing.[1] Most novel drug candidates fail during development, either because of unacceptable toxicity or because they do not prove efficacy in the targeted disease.[9]

Related: Investigational New Drug (IND), Priority review, Phase 3 trial, Complete response letter

Sources

  1. "The Drug Development Process" . U.S. Food and Drug Administration. January 4, 2018. Archived from the original on October 18, 2014 . Retrieved May 1, 2018 . web.archive.org; "The Drug Development Process. Step 4: FDA Drug Review" . U.S. Food and Drug Administration. January 4, 2018. Archived from the original on October 23, 2014 . Retrieved May 1, 2018 . web.archive.org (via Wikipedia: New Drug Application)
  2. "The Drug Development Process. Step 4: FDA Drug Review" . U.S. Food and Drug Administration. January 4, 2018. Archived from the original on October 23, 2014 . Retrieved May 1, 2018 . web.archive.org (via Wikipedia: New Drug Application)
  3. Gad, Shayne Cox (2008). Pharmaceutical Manufacturing Handbook: Production and Processes . John Wiley & Sons. ISBN 9780470259801 . books.google.com (via Wikipedia: New Drug Application)
  4. "The Drug Development Process. Step 3: Clinical Research" . U.S. Food and Drug Administration. January 4, 2018 . Retrieved May 1, 2018 . [ dead link ] fda.gov (via Wikipedia: New Drug Application)
  5. Food, Drug, and Cosmetic Act, Section 505; 21 USC 355]; "Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products" . www.fda.gov . FDA. January 27, 2020. Archived from the original on August 30, 2020. web.archive.org (via Wikipedia: New Drug Application)
  6. "Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence" . www.fda.gov . FDA. November 30, 2023. Archived from the original on February 26, 2024. web.archive.org (via Wikipedia: New Drug Application)
  7. "Merck KGaA Receives Refuse To File Letter From FDA On Cladribine Tablets New Drug Application" . medicalnewstoday.com . Archived from the original on March 5, 2010 . Retrieved April 30, 2018 . web.archive.org (via Wikipedia: New Drug Application)
  8. "Cadence Pharmaceuticals Announces Priority Review and Acceptance of NDA Submission for Acetavance for Treatment of Acute Pain and Fever" . drugs.com . Archived from the original on July 11, 2017 . Retrieved April 30, 2018 . drugs.com (via Wikipedia: New Drug Application)
  9. "The Drug Development Process" . U.S. Food and Drug Administration (FDA). 4 January 2018. Archived from the original on August 26, 2019 . Retrieved 21 March 2020 . web.archive.org; Strovel J, Sittampalam S, Coussens NP, Hughes M, Inglese J, Kurtz A, et al. (July 1, 2016). "Early Drug Discovery and Development Guidelines: For Academic Researchers, Collaborators, and Start-up Companies" . Assay Guidance Manual . Eli Lilly & Company and the National Center for Advancing Translational Sciences. PMID 22553881 . ncbi.nlm.nih.gov (via Wikipedia: Drug development)

Checked 8 October 2026. How we check sources