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 »We’re Speaking Out on Health Issues
NCHR scientists and health policy experts provide written and oral statements on a wide range of topics.
Here are many of the ways we have been Speaking Out on Health Policy Issues for the last few years. Whether the topic is legislation intended to cure diseases, proposed bans on BPA or other chemicals that disrupt your hormones, the importance of including women, people of color, and patients over 65 in clinical trials, or many other topics, you’ll gain a better understanding of our evidence-based analyses by reading these letters, statements, and testimony.
Here are the ways we have been Speaking out on Medical Treatments and Products, such as prescription drugs and medical devices that the FDA is considering approving, or is considering taking off the market because of serious risks. Whether the topic is Chantix, Addyi, Yaz, Essure, or medical products you’ve never heard of, you can find out more about what is known and not known about the safety and effectiveness of a wide range of products by looking through this section of our website.
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.
Read More »NCHR Comments on AHRQ’s Mindfulness-Based Interventions for Mental Health and Wellbeing in Children and Adolescents
The following written comment was submitted by the Health Policy Director, Dr. Amanda Berhaupt at The National Center for Health Research’ (NCHR) to the Agency of Health Research and Quality (AHRQ). AHRQ requested comments on the protocol for the Mindfulness-Based Interventions (MBI) for Mental Health and Wellbeing in Children and Adolescents: A Systematic Review by […]
Read More »NCHR Testimony on Talasoparib at the FDA Advisory Committee
May 21, 2025: NCHR’s Amanda Berhaupt testified at the FDA Advisory Committee that since the TALAPRO-2 trial shows Talzenna with Xtandi benefits castration-resistant metastatic prostate cancer patients with HRRm tumors but not those without, the FDA should not expand approval to HRRm-negative patients. The FDA Committee agreed.
Read More »NCHR Testimony on Glofitamab-gxbm at the FDA Oncology Drugs Advisory Committee
May 20, 2025: NCHR’s Amanda Berhaupt testified at the FDA Advisory Committee that since Glofitamab trial shows Asian patients with Diffuse Large B Cell Lymphoma patients do well but US and European patients do poorly and STARGLO had too few US patients to generalize results, the Genentech trial does not confirm safety and efficacy for DLBCL patients. The FDA Committee agreed.
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