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 »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.
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or not activities performed on medical devices are considered “remanufacturing” or “servicing,” and we support the draft guidance’s clarity on how to correctly classify a procedure.
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 »NCHR’s Comments to CMS on the 2022 Medicare Physician Fee Schedule
September 13, 2021: We support the continued funding of telehealth services for mental health appointments, though additional data needs to be collected and patient preferences need to be taken into account.
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