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U.S. Department of Health and Human Services

For Industry

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How do I go about getting a drug approved?

Before a drug can be tested in people, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it's likely to be safe and work well in humans. Next, a series of tests in people is begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit.

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 resources provide summaries on NDA content, format, and classification, plus the NDA review process:

Read more about the Overview of the Sequence of Drug Development Activities: PDUFA Activities in Drug Development (PDF - 144KB)

Relevant Resources

Manual of Policies and Procedures (MaPP) 4180.4 NDAs/BLAs: Using the 21st Century Review Process Desk Reference Guide (PDF - 37KB)

CDER 21st Century Review Process Desk Reference Guide (PDF - 1246KB)

The New Drug Development Process: Steps from Test Tube to New Drug Application Review

Guidance for Industry End-of-Phase 2A Meetings (PDF - 164KB)

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