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Updated FDA Draft Guidance Instructs Sponsors on Content, Format, Timing, and Procedures for Submitting Diversity Action Plans for...

Back in 2022, we wrote about U.S. Food and Drug Administration’s (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.”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

Future Expansion of Sunshine Act Reporting to Cover Additional Prescribers

On October 24, President Trump signed into law the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act)....more

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