Bloomberg Law News, July 12, 2023: NCHR says the FDA black box warnings about brain swelling and bleeding and other cautions about who is most likely to be harmed by Alzheimer’s drug Leqembi will help protect patients with mild cognitive impairment, but only if their doctors pay attention and accurately discuss the risks vs. uncertain benefits with patients and family members.
Read More »Author: Caroline Bradford
No more FDA adcomm votes? Reforms brew as new research highlights decline in meetings
Endpoints News, July 7, 2023: FDA wants to revamp its Advisory Committee meetings but will they make them better or worse? The votes aren’t the problem. We explain that the conflicts of interest of committee members is “outrageous.”
Read More »NCHR Comments on FDA’s Patient-Focused Drug Development Draft Guidance
July 5, 2023: NCHR supports the FDA’s efforts to increase patient engagement in medical product development and emphasizes the need for diverse and representative samples, the importance of transparency in data analysis, and the use of COA-based endpoints in regulatory decision-making and drug labeling.
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.
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