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FDA Draft Guidance Instructs Sponsors on Content and Timing of Diversity Plans for Clinical Trials

For several years, FDA has advanced a policy of increasing diversity in clinical trial populations. During that time, FDA issued broad policy statements, as well as guidance on improved data collection and steps sponsors...more

FDA Enforces ClinicalTrials.gov Results Posting Requirements, Including Threats of Financial Penalty

Clinical trials requiring registration on ClinicalTrials.gov generally must have results submitted no later than one year after the study’s primary completion date. In the past, some companies delayed updating a clinical...more

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