Brief Introduction of Guidance on Pharmacogenomics in the USA and Its Implication for China

Abstract

Abstract: Objective To classify and introduce the FDA's guidance on pharmacogenomics and provide suggestions to conduct the application of pharmacogenomics in China. Methods The materials of guidance on pharmacogenomics in FDA official website were researched, and the related literatures were searched and analyzed. Results FDA has issued a series of guidance on genomic sampling, sample coding, data submission, studies in clinical trials and recommendations for labeling to ensure the application of pharmacogenomicsin the USA In this section, the guidance Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling was elaborated as a case here, and three chapters were emphatically introduced. Conclusion The FDA's guidance on pharmacogenomics could give us valuable reference for new drug development and post-marketing drug evaluation.

Key words: pharmacogenomics, guidance, adverse reaction

CLC Number:

WANG Tao, SONG Hai-bo, DONG Duo. Brief Introduction of Guidance on Pharmacogenomics in the USA and Its Implication for China[J]. Chinese Journal of Pharmacovigilance, 2017, 14(11): 662-665.

References

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