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Opinion: FDAs Plan to Diversify Trial Participation Criticized
In response to a law passed two years ago, the FDA was directed to assess the extent to which women and minorities are represented in clinical trials and also devise a plan to bolster their participation. The requirement was made in response to concerns that drugs and devices may often be used by subsets of the population on whom the products were not actually tested.
Well, the FDA released its plan the other day and it was met with what could best be described as faint praise. In particular, a pair of consumer advocacy groups says the biggest issue is that the so-called Action Plan lacks the sort of teeth needed to generate real change. They also complain the plan fails to require drug and device makers to contain specific demographic information in product labeling.
They acknowledged the plan does contain several constructive steps, such as working with drug and device makers to revise product applications with enhanced information on “demographic subgroups;” strengthening FDA reviewer training so the need for demographic data is communicated; improving FDA systems for collecting and analyzing such data; and updating or finalizing guidance for industry.
Read the article here: http://on.wsj.com/1qDQ2SK
Source: The Wall Street Journal
Advancing Women's Health: CVS Health Leader on Access, Technology, and Breaking Stigmas
December 5th 2024On this episode of Managed Care Cast, we speak with CVS Health's vice president and chief medical officer for women's health and genomics about advancements and challenges in women's health, focusing on care access, technology, and maternal outcomes.
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Contributor: Maternal Health Outcomes Are a Systemic Signal
July 15th 2025Jayme Ambrose, DNP, RN, CCM, of Adobe Population Health, explores how addressing social determinants of health transforms maternal care delivery, reduces disparities, and improves outcomes for mothers and infants.
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Discussing Sexuality, Mental Health With AYA Patients Amid the Hematological Treatment Journey
June 14th 2025Adolescent and young adult (AYA) patients with hematological diseases have unique needs that require a multidisciplinary strategy to ensure their mental and sexual well-being during and beyond treatment, clinicians and patients agreed.
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