August 14, 2025: National Center for Health Research written comment urges FDA to use PDUFA user fees to improve drug safety and effectiveness, not just faster approvals. All programs included in Commitment Letter should emphasize the scientific standards and evidence that will ensure that drugs and biologics have meaningful benefits for patients that outweigh any risks.
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NCHR Public Comment on Improving the Generic Drug User Fee Act (GDUFA IV)
National Center for Health Research’s written comment on GDUFA IV urges the FDA to use generic drug user fees to pay for staff and resources that improve generic drug safety and equivalence, not just speedy review. We point out that hundreds of generic drugs that are still for sale have been found to be contaminated, the wrong dosage, or otherwise unsafe or ineffective for patients. To regain the trust of all patients and health professionals, FDA needs to do more testing and inspections and make sure that bad drugs are recalled.
Read More »FDA Public Meeting on MDUFA VI: Invited Presentation of Dr. Diana Zuckerman
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.
Read More »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.
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