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Regulatory Requirements for the Drug Approval Process in ...

At the conclusion of the review of an NDA, there are 3 ... on suggestions by the FDA. The next step is phase I clinical trials (1-3 years) on human subjects (~100). The drug's safety profile and ... biotechnology processes, such as genetic engineering. …

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  Drug, Requirements, Regulatory, Suggestions, Approval, Biotechnology, Conclusions, Regulatory requirements for the drug approval

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