12.17.20 FDA FY2020 Drug Inspection Observations And Trends
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Featured Editorial
This article presents the FDA s most recent publication of GMP drug inspection data, which address drug inspections conducted in FY2020. We examine data from FY2020 and evaluate five years worth of trends in drug GMP inspection enforcement.
12.16.20 FDA s Office Of Minority Health And Health Equity Addresses Patient Diversity
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Featured Editorial
By Ed Miseta, chief editor, Clinical Leader
The diversity of patients participating in clinical trials continues to be a problem in drug development. As sponsors and sites attempt to address the problem, regulators are also doing their best to address the issue. One person deeply involved in this issue is Rear Admiral Richardae Araojo, the associate commissioner for minority health and director of the Office of Minority Health and Health Equity at the FDA.