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 »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 Comments on AHRQ’s draft review on Maternal and Child Outcomes Associated with the Special Supplemental Nutrition Program
November 2, 2021: NCHR endorses the systematic review of WIC, an important program that aims to safeguard the health of low-income, nutritionally at-risk pregnant and postpartum women and children under the age of 5 years old.
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 »Testimony of Dr. Diana Zuckerman, NCHR, at the FDA PDUFA Meeting, September 28, 2021
September 28, 2021: After reviewing FDA’s PDUFA VII plans, I have concerns about the performance goals and policies that the FDA has negotiated with industry behind closed doors.
Read More »NCHR’s Comments to FDA on the Remanufacturing of Medical Devices
September 22, 2021: We agree with the FDA that clarification is needed of whether or not activities performed on medical devices are considered “remanufacturing” or “servicing,” and we support the draft guidance’s clarity on how to correctly classify a procedure.
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