On September 28, the US Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRMs) to harmonize the…
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In June, the Food and Drug Administration (FDA) issued a draft guidance, "Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria,…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…
Read MorePRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s draft guidance "Considerations for Inclusion of Adolescent…
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PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s draft guidance "Pregnant Women: Scientific and Ethical…
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