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FDA Requirements for New Drugs and Biologics. Investigational new drug (IND) means a new drug or biological drug that is used in a clinical investigation. The
This guidance is intended to assist sponsors of investigational new drugs and applicants for approval of a new drug in evaluating whether their new drug
FDA Requirements for New Drugs and Biologics Investigational new drug (IND) means a new drug or biological drug that is used in a clinical investigation.
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New Drug Application Type The type of new drug application approval. New Drug Applications (NDA or innovator) are N . Abbreviated New Drug Applications (ANDA or generic) are A .
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