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Tag: policy comments

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PRIM&R Responds to NIH Strategic Plan Framework

(PRIM&R) Public Responsibility in Medicine and Research

In 2015, NIH solicited public input on an agency-wide strategic plan framework for the subsequent five years in response to…

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PRIM&R’s Comments on NIH’s Draft Policy for Data Management and Sharing and Supplemental Draft Guidance

(PRIM&R) Public Responsibility in Medicine and Research

On November 8, 2019, the National Institutes of Health (NIH) released its Draft NIH Policy for Data Management and Sharing…

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Join PRIM&R in Commenting on International Conference of Harmonization’s Revised Guideline

(PRIM&R) Public Responsibility in Medicine and Research

The International Conference of Harmonization (ICH), which is made up of the regulatory bodies and pharmaceutical trade associations of key…

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PRIM&R’s Response to FDA’s Draft Guidance on Enhancing the Diversity of Clinical Trial Populations

(PRIM&R) Public Responsibility in Medicine and Research

In June, the Food and Drug Administration (FDA) issued a draft guidance, "Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria,…

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PRIM&R’s Response to FDA’s Draft Guidance on “Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients”

(PRIM&R) Public Responsibility in Medicine and Research

In March, the Food and Drug Administration (FDA) issued a guidance, "Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric…

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PRIM&R advances the highest ethical standards in the conduct of research. We accomplish this mission through education, membership services, professional certification, public policy initiatives, and community building.