July 19, 2023: NCHR urged FDA to require drug sponsors and their REMS administrators to test proposed changes to REMS systems prior to implementation. FDA should also require stakeholder input from prescribers in all stages of developing, implementing, and tracking a REMS modification.
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Patient, Consumer, and Public Health Coalition Letter to FDA Commissioner Califf Regarding FDA Advisory Committee Meetings
July 7, 2023: The Coalition expressed our strong concerns when the Food and Drug Administration (FDA) Center Directors publicly undermine or privately overrule the recommendations of their own scientists’ and statisticians’ regarding applications for accelerated approval and full approval.
Read More »NCHR Comments on FDA’s Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising
June 26, 2023: In our public comment, NCHR supports the FDA’s survey on evaluating patients’ understanding of quantitative information provided in prescription drug advertising. We strongly recommend adding an assessment of comprehension for factors such as relative risk, absolute risk, relative benefit, and absolute benefit of drugs. We urge the FDA to include a diverse demographic of participants in the one-on-one interview informing the survey and provide details about the number of interviews OPDP plans to conduct.
Read More »NCHR Comments on USPSTF Draft Recommendation for Oral Health in Adults
June 20, 2023: In our public comment, NCHR agrees with USPSTF that there is insufficient evidence to recommend routine oral health screening of adults by primary care clinicians. We urged that new research be conducted to determine the benefits and harms of screening, primary care counseling, dental referral, and oral health preventive interventions administered in primary care settings for adults.
Read More »NCHR Comments on USPSTF Draft Recommendation for Oral Health in Children and Adolescents
June 20, 2023: In our public comment, NCHR agrees with USPSTF that there is insufficient evidence to recommend routine oral health screening by primary care clinicians in children ages 5 to 17 years. Available research evidence is limited to studies assessing oral health preventive interventions that were administered by dental professionals or in supervised school settings, but not in primary care settings. We strongly recommend that well-designed research be conducted to fill these gaps.
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