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The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
In years past, questions have been raised about the adequate and equal inclusion of women and people from racial, ethnic and other minority groups in the clinical studies that test new medical products. The FDA has been working since the 1980s to increase participation of diverse subgroups in clinical trials, and in August 2014, the agency released its Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data.
This plan outlines the agency’s recommendations to increase the quality of demographic subgroup data, encourage the participation of a greater diversity of subjects in clinical trials, and increase the availability and transparency of demographic subgroup data. In November 2014, FDA’s Center for Drug Evaluation and Research (CDER) launched the Drug Trials Snapshots initiative as a first step to help make clinical trial data more available and transparent. The snapshots will cover all new molecular entity (NME) and original biologic drugs approved beginning in January 2015.On Monday, April 27, 2015, at 1pm (EDT), Dr. John Whyte, Director of CDER’s Professional Affairs and Stakeholder Engagement (PASE) staff will describe how the Drug Trials Snapshots provide consumers and other stakeholders with information about who participated in the clinical trials that supported FDA approval of new drugs. Dr. Whyte will also discuss how the snapshots help consumers to understand any differences in the benefits or side effects among sex, race and age groups.
This plan outlines the agency’s recommendations to increase the quality of demographic subgroup data, encourage the participation of a greater diversity of subjects in clinical trials, and increase the availability and transparency of demographic subgroup data. In November 2014, FDA’s Center for Drug Evaluation and Research (CDER) launched the Drug Trials Snapshots initiative as a first step to help make clinical trial data more available and transparent. The snapshots will cover all new molecular entity (NME) and original biologic drugs approved beginning in January 2015.On Monday, April 27, 2015, at 1pm (EDT), Dr. John Whyte, Director of CDER’s Professional Affairs and Stakeholder Engagement (PASE) staff will describe how the Drug Trials Snapshots provide consumers and other stakeholders with information about who participated in the clinical trials that supported FDA approval of new drugs. Dr. Whyte will also discuss how the snapshots help consumers to understand any differences in the benefits or side effects among sex, race and age groups.
For more information including how to attend, please visit: FDA Webinar.
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