NDA and BLA Filing Checklist

This checklist explains how to prepare a New Drug Application (NDA) or Biologics License Application (BLA) for submission to the U.S. Food and Drug Administration (FDA). The checklist covers what must be included in an NDA/BLA, how it should be formatted, and how to submit the completed application to the FDA.

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  Follow FDA rulemaking activity related to the IND and BLA process.

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