2021-06-27 20:40 To ensure the healthy growth of the pharmaceutical market, while encouraging innovation and research, the US Food and Drug Administration (FDA) has developed a series of comprehensive measures and management tools. In IND application or NDA submission, you need to submit persuasive statistics including chemistry, manufacturing and controls (CMC) data, non-clinical pharmacology and toxicology data, human pharmacokinetics and bioavailability data, microbiological data, clinical data, safety data update reports, statistical data, case reports, related patents, samples, packaging and labels.
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