New Drug Applications (NDAs) and Biologics License Applications (BLAs)

The FDA interacts with sponsors throughout the drug development and approval process in order to guide and regulate testing procedure. Official review of a new drug’s safety and effectiveness, however, only begins after clinical trials have been concluded, with the submission of a New Drug Application, or NDA. An NDA contains all of the data that researchers have gathered about a drug through clinical trials, plus manufacturing, labeling, biological, and chemical information to determine the drug’s appropriate use. CDER uses this information to determine whether or not a drug is sufficiently safe and effective to be approved. Biologics License Applications, or BLAs, are similar documents submitted by biologics developers for review and approval. 

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