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FDA NDA Application – New Drug

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The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. 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 of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged. The following is a list of FDA's review and approval requirements:

  • IND package
  • The results and analysis of clinical trials
  • Labeling (Official instructions for use)
  • On-site inspections of manufacturing sites and sites where significant clinical trials are performed

Key standards in NDA review and approval:

  • Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.
  • Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain.
  • Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity.

Service

  • Preparing and organizing Pre-NDA meeting
    • Raw materials and products
    • Process and control
    • Preclinical trial data
    • Phase I to III clinical trial data
  • Correspondence with FDA and holding Pre-NDA meeting
  • Rectification according to FDA’s advices
  • Preparing and submitting NDA package
    • Preparing and organizing NDA data
    • NDA drafts review and final versions
    • Submitting NDA to FDA as the US agent

Link to "Services" for more information.