Article

Comparison of Good Clinical Practice Inspection Processes for Marketing Applications between the United States Food and Drug Administration and the European Medicines Agency

2022-06-02

Abstract excerpt

<title>Abstract</title> <p>Background The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) began collaboration on Good Clinical Practice (GCP) inspections for marketing applications since 2009. The main characteristics of the GCP inspection processes between FDA and EMA were never evaluated. This is the first analysis comparing the GCP inspection processes between the two agencies. Me...

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Literature Corpus work: 43820084-9efd-5aa5-97a1-a28d692200d3
DOI: 10.21203/rs.3.rs-1667001/v1

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