New Drug Application

New Drug Application (NDA) is the process by which pharmaceutical companies formally propose that the U.S. Food and Drug Administration (FDA) approve a new pharmaceutical for sale and marketing in the United States.

History

The NDA is the result of a series of drug development activities. These activities include pre-clinical testing, clinical trials, and post-market surveillance studies. The goal of the NDA is to provide enough information to permit the FDA to reach the following key decisions:

• 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

Process

The FDA reviews the NDA with three major concerns: safety and effectiveness in the drug's proposed use(s), appropriateness of the proposed labeling, and adequacy of manufacturing methods to assure the drug's identity, strength, quality, and purity.

See also

• Investigational New Drug
• Abbreviated New Drug Application
• Biologics License Application
• Regulation of therapeutic goods
• European Medicines Agency

External links

• FDA New Drug Application (NDA) page

New Drug Application Resources
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