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Covance Blog
In January 2020 the Food and Drug Administration (FDA) reviewed its 2017 draft content and published finalized guidance for in vitro and clinical drug interaction studies. We’ve summarized the the key changes and implications for in vitro drug-drug interactions (DDI) testing in this post, but if you would like more …
Updated 2020. The FDA has now approved the DDI regulations. Below is the article as originally published. In 2018 the FDA and several other regulatory bodies are expected to enact and enforce more laws related to the requirements for nonclinical drug-drug interaction (DDI) studies prior to an IND. A key …