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 »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.
Patient, Consumer, and Public Health Coalition Comments Regarding the FDA Draft Guidance Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions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.
Read More »Patient, Consumer, and Public Health Coalition Comments to FDA on their Guidance for Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission
December 6, 2023: In its public comment, members of the Patient, Consumer, Public Health Coalition told FDA that if a predicate device for 510(k) review does not align with the best practices identified in the FDA guidance, the device should be submitted to De novo or PMA instead.
Read More »NCHR Comments on Consumer Product Safety Commission Scientific Integrity Policy
December 4, 2023: NCHR urged CPSC to strengthen protections for scientists against retaliation and instill consequences for violations of the scientific integrity policy.
Read More »Patient, Consumer, and Public Health Coalition Comments on the FDA Proposed Rule Regarding Laboratory Developed Tests
December 4, 2023: The PCPH Coalition supported the FDA proposed rule on lab-developed tests (LDTs) to diagnose diseases and genetic issues, with the exception of FDA’s proposed increased use of third-party reviewers.
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