New drug application

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The 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. The goals of the NDA are to provide enough information to permit FDA reviewers to establish the following:

• Is the drug safe and effective in its proposed use(s), and do the benefits of the drug outweigh the risks?

• Is the drug’s proposed labeling (package insert) appropriate, and what should 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?

To legally gather this data on safety and effectiveness in the U.S., the maker must first obtain an Investigational New Drug (IND) designation from FDA.

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 formulation are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged. Once approval of an NDA is obtained, the new drug can be legally marketed starting that day in the U.S.

Biologics, such as vaccines and many recombinant proteins used in medical treatments are approved by FDA via a Biologic License Application (BLA), rather than an NDA. Manufacture of biologics is considered to differ fundamentally from that of less complex chemicals, requiring a somewhat different approval process.^[1]

Generic drugs that have already been approved via an NDA submitted by another maker are approved via an Abbreviated New Drug Application (ANDA), which does not require all of the clinical trials normally required for a new drug in an NDA.^[2] Biological drugs, including most recombinant proteins are considered ineligible for an ANDA under current US law.^[3]

Reference

1. ↑ FDA, CBER The Biologics License Application Process: An Overview
2. ↑ FDA, CDER Office of Generic Drugs
3. ↑ Rouhi, A.M. “Beyond Hatch-Waxman: Legislative action seeks to close loopholes in U.S. law that delay entry of generics into the market” Chem & Eng News 80(38):53-59

See also

• Regulation of therapeutic goods
• Investigational New Drug
• Kefauver Harris Amendment
• Active ingredient
• Drug development
• Clinical trial
• Food and Drug Administration (FDA)
• European Medicines Agency (EMEA)
• Ministry of Health, Labour and Welfare (Japan)