We agree that the FDA should immediately develop clear guidelines for labeling that addresses safety and effectiveness of drugs in the geriatric population.
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 Statement at FDA Medical Devices Advisory Committee Meeting on the VisAbility Micro Insert
November 9, 2020. The risks for this device are notable, especially considering that it is unnecessary because other, non-invasive and approved treatments are available.
Read More »NCHR Statement at FDA Alzheimer’s Advisory Committee Meeting On Aducanumab
NCHR’s Testimony at FDA Meeting for Reducer Circulatory System Device
The data provided thus far simply do not provide enough evidence that there are benefits outweighing the risks for the Reducer, a permanent device.
Read More »Diana Zuckerman’s Public Health presentation at FDA MDUFA Meeting, October 27, 2020
MDUFA performance goals need to be more patient-centered by including specific metrics pertaining to safety and effectiveness, both pre-market and post-market, and improving patients and consumer advocates’ access to meet with FDA decision-making officials. That will help provide the safeguards that patients and consumers deserve.
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