September 30, 2021: Dr. Diana Zuckerman testifies to the FDA regarding the lack of diversity and inclusion in medical device trials pointing out that most medical companies do not adequately study safety and effectiveness in women, older patients, and people of color.
Read More »On Medical Treatments & Products
NCHR’s Testimony to FDA Regarding Boosters for Pfizer’s COVID-19 Vaccine
September 17, 2021: The data provided for this meeting do not allow us to draw confident conclusions, and a premature decision will make it impossible to do the research necessary to draw scientific conclusions.
Read More »NCHR’s Testimony to FDA on the TriGUARD 3 Device
August 3, 2021: The TriGUARD 3 device is not shown to be substantially equivalent or safe or effective and should not be cleared for market.
Read More »NCHR’s Testimony to FDA on the TransMedics® Organ Care System™ (OCS) Liver System
July 14, 2021: We conclude that the OCS system has additional risks compared with traditional standard of care, without any benefits for survival.
Read More »Scientific Coalition Letter on Aduhelm to HHS Inspector General, CMS, and Congress
July 7, 2021. As organizations working to promote and protect science for the public good, we are writing to express our concern about the lack of scientific evidence to support the FDA’s recent accelerated approval of Biogen’s Aduhelm (aducanumab) as a drug intended to slow cognitive damage caused by Alzheimer’s disease.
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