The FDA issued draft guidance for industry, titled “Use of Data Monitoring Committees in Clinical Trials,” to assist sponsors of…
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FDA and the Office for Human Research Protections (OHRP) issued a 16-page draft guidance, entitled “Key Information and Facilitating Understanding…
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On September 28, the US Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRMs) to harmonize the…
Read MoreIn June, the Food and Drug Administration (FDA) issued a draft guidance, "Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria,…
Read MoreIn March, the Food and Drug Administration (FDA) issued a guidance, "Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric…
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