October 30, 2024: Tess Robertson Neel testified at the FDA Patient Engagement Device Advisory Panel on behalf of the Patient, Consumer, and Public Health Coalition regarding informed consent. We support the FDA’s proposed improvements, suggests a short, easy to read checklist format to improve fully informed consent, and highlights the need to enforce FDA recommendations or improve incentives for compliance.
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Testimony of Laura Lytle at the FDA Patient Engagement Device Advisory Committee Meeting
October 30, 2024: NCHR’s Laura Lytle testified at the FDA Patient Engagement Device Advisory Panel meeting in support of the FDA’s proposed guidance for informed consent, but suggested 4 key areas for improvement: using a short, simple checklist to ensure that patients understand the risks; focusing on informed consent as a process not a document; simple summaries of key information; and ensuring patient privacy.
Read More »NCHR Public Comment to CDC Safety Office on COVID Vaccine Research and Communications
October 11, 2024: We presented our public comment at the NASEM Review of CDC COVID-19 Vaccine Safety Research and Communications Meeting 3 on how CDC could improve research and communications regarding COVID-19 vaccines. We said CDC needs to be clear on what is known and not known and needs to quantify what is known about adverse events and complications from vaccines.
Read More »NCHR Public Comment on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies
September 26, 2024: NCHR appreciates the improvements made in the 2024 FDA draft guidance for Diversity Action Plans but the draft lacks incentives to encourage companies to comply. The indication and label should reflect the evidence for sex, race, ethnicity, and ages of patients studied. Approval should only be for patients for whom clear evidence of safety and effectiveness was provided.
Read More »NCHR Letter for the Record for Hearing on the Consumer Product Safety Commission Budget
July 22, 2024: NCHR’s letter for the record for the House hearing: “The Fiscal Year 2025 Consumer Product Safety Commission Budget” describes the accomplishments of the CPSC and urges Congress to support CPSC’s life-saving work evaluating consumer products, especially those for children, in order to keep all of us safe.
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