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| Investigational New Drug IND Application | A drug sponsor's request to the Food and Drug Administration (FDA) for approval to test an investigational drug in humans. FDA review of an investigational new drug (IND) application ensures that the drug is safe for testing in humans and that testing will not put study participants at unreasonable risk. |
| New Drug Application NDA | A drug sponsor's request to the Food and Drug Administration (FDA) for approval to sell and market a new drug in the United States. A new drug application (NDA) includes enough information for the FDA to determine whether the new drug is safe and effective; whether the drug's benefits outweigh its risks; whether the proposed drug label (package insert) is appropriate; and whether the drug manufacturing standards are adequate. |