New drug application

New Drug Application (NDA) is the process by which drug sponsors 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 legislation of the NDA was first passed as part of the Food, Drug, and Cosmetic Act in 1938. The legislation was intended to ensure the safety of drugs being marketed in the U.S. and to prevent the sale of ineffective drugs.

Process

The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA. The application is submitted by the company responsible for developing the drug. The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics.

Review

Once the NDA is submitted, the FDA has 60 days to decide whether to file it so that it can be reviewed. If it’s filed, the FDA review team is assigned to evaluate the sponsor's research on the drug's safety and effectiveness.

Postmarketing Surveillance

After an NDA is approved, the new drug becomes available for physicians to prescribe. As people use the drug, side effects (also known as adverse events) are reported to the FDA. If unexpected adverse events are reported, the FDA can withdraw the drug from market.

See also

• Drug development
• Food and Drug Administration
• Investigational New Drug

New drug application Resources
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