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Updated FDA Draft Guidance Instructs Sponsors on Content, Format, Timing, and Procedures for Submitting Diversity Action Plans for...

Back in 2022, we wrote about U.S. Food and Drug Administration’s (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.” On June...more

Negotiating the Tension Between Transparency and Privacy

Making individual patient-level data available for other research presents companies with challenges, but researchers and companies can take steps to minimize the risks. Originally published in Drug and Medical Device,...more

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