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What are NDAs / BLAs and why are they important in drug development?

NDAs and BLAs are FDA applications required for the medical use of a substance. According to the FDA, a Biologic License Application (BLA) is a request for permission to introduce a biologic product, a medical product from a natural source, into interstate commerce. The document includes applicant information, product manufacturing procedures, pre-clinical studies, clinical studies and labeling details. A New Drug Application (NDA) is the formal request to market a new pharmaceutical product. The application contains similar types of information as a BLA, including data collected from clinical trials and is reviewed by the FDA.

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Relevant publications

• FDA: Overview of New Drug Applications
• FDA: Overview of Therapeutic Biologic Application

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