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Regulatory Agencies

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In vitro drug-drug interaction (DDI) regulation updates in the FDA’s 2020 guidance: A summary

by Covance Inc.updated on Tuesday, August 4, 2020Sunday, July 19, 2020

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 …

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A comparison of FDA, EMA & PMDA regulatory guidance for in vitro drug-drug interaction (DDI) assessments

by Covance Inc.updated on Wednesday, August 26, 2020Monday, June 29, 2020

This online whitepaper article explores the 2020 regulatory changes in U.S. FDA guidance1 and recommendations, compared to existing EU EMA2 and Japanese PMDA3 guidance for in in vitro drug–drug interaction (DDI) assessments.

Copyright © 2020 Covance Inc. All rights reserved.