November 3, 2021: We are concerned about the conflicting data on EVAR devices, and the reliance on 5-year studies that include different iterations of a device.
Read More »On Medical Treatments & Products
NCHR’s FDA Advisory Committee Testimony on Carbetocin Nasal Spray for Hyperphagia in Prader Willi Syndrome
November 4, 2021. NCHR agrees with FDA criticisms of the evidence. Families urgently need help, but the company should spend a few more months to establish whether this drug is effective and safe for more than 8 weeks – BEFORE FDA considers approving it.
Read More »NCHR’s testimony about Endologix AFX endovascular graft system (EVAR) at the FDA Advisory Panel
November 2, 2021: The evidence does not support the use of the Endologix AFX EVAR devices, and the AFX2 device should not remain on the market while waiting for longer term data to determine if it is as safe as other EVAR devices.
Read More »Testimony of Dr. Diana Zuckerman, NCHR, at the FDA MDUFA Meeting
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 »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 »