NDA
Last step taken by a drug sponsor for securing an approval needed to market a new drug in the United States. A comprehensive document, it comprises of 15 sections including figures and analyses on animal and health studies, drug’s pharmacology, toxicology and dosage, and process of creating the drug. Once submitted, the Food and Drug Administration (FDA) has 60 days to determine whether it is subject for review or rejected.
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Risk Averse
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