November 24, 2023: NCHR urges the FDA to address the issue of methylmercury exposure to children and pregnant women through canned tuna. We urge the FDA to reevaluate current standards and utilize clear labeling to inform consumers of the risk.
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NCHR’s Comments on FDA’s Draft Guidance for Medical Devices with Indications Associated with Weight Loss
November 14, 2023: Medical Devices with indications associated with weight loss that are affected by this FDA draft guidance have many implications for the health and quality of life of many individuals. For this reason, it is vital for FDA guidance to be based on large sample sizes, stringent controls, and extensive follow-up to ensure the safety and efficacy of such medical devices.
Read More »NCHR’s Comment on the ATF’s Proposed Rule on the Definition of “Engaged in the business”
December 5, 2023: NCHR supports the ATF’s proposed rule that will implement an updated definition of “engaged in business” so that anyone engaged in selling firearms “for profit” will be deemed as sellers required to do background checks on their patrons. This new rule will require trade shows and online retailers to be regulated the same as brick-and-mortar establishments.
Read More »Patient, Consumer, and Public Health Coalition Comments Regarding the FDA Draft Guidance Recommendations for Evidentiary Expectations for 510(k) Implant Devices
December 6, 2023: In its public comment, members of the Patient, Consumer, Public Health Coalition urged FDA to institute stronger standards to determine clinically meaningful substantial equivalence for 510(k) clearance.
Read More »Patient, Consumer, and Public Health Coalition Comments Regarding the FDA Draft Guidance Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions
December 6, 2023: In its public comment, members of the Patient, Consumer, Public Health Coalition urged FDA to rely more on scientifically credible types of clinical data for 510(k) to ensure patients’ health and safety.
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