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FDA Issues Draft Guidance Recommending

On April 13, the Food and Drug Administration (FDA) published a new draft guidance that, for the first time, recommends that sponsors of clinical trials for submission to .

Drug administration safety innovation actOncology centerHuman servicesNational institutes of healthDrug administrationOffice of minority healthDepartment of healthEquitable research studies for everyone trials actKey takeawaysInvestigative new drugBiologics license applicationNew drug applicationInvestigational device exemptionEthnicity diversity planClinical trialEnrollment practices

FDA Guidance on Diversity Plans in Clinical Trials: What You Need to Know | Bass, Berry & Sims PLC

The United States Food and Drug Administration (FDA) issued draft guidance on April 13, 2022, entitled, “Diversity Plans to Improve Enrollment of Participants from Underrepresented.

United statesDepartment of healthEuropean medicines agencyAdvisory committee on human research protectionsDrug administrationHuman services office of the inspectorBerry simsUnited states foodImprove enrollmentUnderrepresented racialEthnic populationsEthnicity diversity planDiversity planInvestigational new drugInvestigational device exemptionBiologics license application

FDA Issues Draft Guidance Recommending Race and Ethnicity Diversity Plans for Clinical Trial Sponsors | Foley Hoag LLP

Key Takeaways: The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials. FDA’s.

Drug administration safety innovation actOncology centerFoley hoagHuman servicesNational institutes of healthDrug administrationBiden administrationOffice of minority healthDepartment of healthEquitable research studies for everyone trials actInvestigative new drugBiologics license applicationNew drug applicationInvestigational device exemptionEthnicity diversity planClinical trial populations

FDA Wants to See Diverse Participation in Clinical Trials

The FDA has issued a new draft guidance to enroll more patients from underrepresented racial and ethnic groups to improve clinical trial diversity.

Robertm califfOffice of minority healthDrug administrationHealth equityBiden administrationDiversity in clinical trials initiativeImprove enrollmentUnderrepresented racialEthnic subgroupsClinical trialsEthnicity diversity planMinority healthCancer moonshotAccessed april

Draft guidance to improve US clinical trial diversity

The new guidance asks sponsors to submit a Race and Ethnicity Diversity Plan outlining how they plan to enrol participants from underrepresented populations.

United statesRobert califfAdministration cancer moonshotOncology centerDrug administrationBiden administrationDiversity in clinical trials initiativeOffice of minority healthRadiological healthHealth equityEthnicity diversity planCancer moonshotMinority healthClinical trials initiativeProject equityDrug evaluation

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