new drug application (nda)

How Is the Safety Data Assessed?

The safety data in an NDA is assessed through a rigorous review process by the FDA. Toxicologists and other experts evaluate the data to ensure that the benefits of the drug outweigh the potential risks. The assessment includes examining the methodologies used in the studies, the relevance of animal models to humans, and the statistical significance of the findings. The goal is to ensure that the drug is safe for its intended use and that any potential risks are manageable.

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