August 4, 2025: Diana Zuckerman presented on behalf of NCHR at FDA’s first public MDUFA VI meeting of 2025. She focused on device performance goals that enhance safety, effectiveness, and transparency prior to FDA approval or clearance, and evaluating safety, effectiveness, and information for patients post-market. A major focus was on user fees being used to improve the data needed for informed consent for patients, consumers, and providers.
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NCHR Testimony regarding Front-of-Package Nutrition Information Labeling
July 15, 2025: NCHR submitted written comments to the U.S. Food and Drug Administration in support of the proposed rule on front-of-package nutrition labeling, recommending stronger, clearer labeling requirements, especially for young children. They suggested additional testing to ensure consumers understand and benefit from the labels, including those with limited literacy or English proficiency.
Read More »PDUFA VIII Statement of Dr. Amanda Berhaupt, Health Policy Director of NCHR
July 14, 2025: NCHR presentation at PDUFA July 2025 user fee meeting focuses on including patients and consumers in negotiations with FDA and industry and adding metrics to ensure post-market safety and meaningful clinical outcomes for prescription drugs.
Read More »GDUFA IV Statement of Dr. Diana Zuckerman, President of NCHR
July 11, 2025: NCHR presentation at GDUFA IV July 2025 user fee meeting focuses on including patients and consumer in negotiations with FDA and industry and including metrics to show improved safety and equivalence for generic drugs.
Read More »NCHR signed on to letter urging the OSTP to provide public comment opportunities
June 20, 2025: NCHR and other non-profit organizations sent a letter to the director of the Office of Science Technology Policy urging them to uphold scientific integrity and explaining that opportunities to provide input will increase public trust in scientific decisions.
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