New Drug Application (NDA)

The vehicle through which drug sponsors formally propose that the regulatory body approves a new pharmaceutical for sale and marketing, and the data gathered during the animal studies and human clinical trials of an investigational new product becomes a part of the New Drug Application (NDA).

New Drug Application (NDA)

Aim of New Drug Application (NDA):

The aims of New Drug Application (NDA) include providing adequate information to permit FDA reviewers to establish the following:

  • Safety and effectiveness of drug,
  • Benefits overweigh risks,
  • Is the drug’s proposed labeling (package insert) appropriate, and what should it contain?
  • Are the methods used in manufacturing (Good Manufacturing Practice, GMP) the drug and the controls used to maintain the drug’s quality adequate to preserve the drug’s identity, strength, quality, and purity? Risk-Benefit.
NDA Contents
Fig: NDA Contents

New Drug Application (NDA) Review Process:

Once the application is submitted, the FDA has 60 days to conduct a preliminary review which will assess whether the NDA is “sufficiently complete to permit a substantive review“.

If everything is found to be acceptable, the FDA will decide if the NDA will get a standard or accelerated review and communicate the acceptance of the application and their review choice in another communication known as the 74-day letter.

NDA Review Process
Fig: NDA Review Process
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