January 6, 2020. The draft document describes how FDA staff evaluates postmarket safety surveillance but lacks some essential information about FAERS, post-marketing studies, the Sentinel Initiative, and safety signal resolution.
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.
Breast Implant Working Group’s Comments on FDA’s Draft Guidance to Improve Patient Communication on Breast Implants
December 23, 2019. We are urging that the FDA require a black box warning and Patient Informed Consent Check List that provides information about the risks of cancer, breast implant illness, and other serious health problems in explicit and easy-to-understand wording that all individuals considering breast implants can understand, regardless of educational level or stress that is inevitable when a person is considering surgery.
Read More »NCHR Comments FDA’s Draft Guidance on Clinical Decision Support Software
December 23, 2019.We appreciate FDA clarifying plans for regulating Clinical Decision Support (CDS) software; however, we have concerns regarding the draft guidance.
Read More »NCHR’s Comments on FDA’s Proposed Rule on Tobacco Product Applications
December 16, 2019. FDA’s proposed requirements for premarket tobacco product applications (PMTAs) defines the extent to which FDA is able to thoroughly evaluate the potential health effects of these products on consumers and, in particular, vulnerable populations such as children and adolescents.
Read More »NCHR Comments on FDA’s Draft Guidance on Post-Market Studies and Clinical Trials
December 20, 2019. Post-market clinical trials and other studies can help inform FDA and the public about the risks and benefits of medical products. However, when they are relied upon to answer questions better addressed prior to approval, or if less effective studies or trials are used, or if studies are delayed and inadequate, they do not provide the intended data that is needed by FDA, patients, and healthcare providers. This adds to the already high cost of medical care.
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