March 23, 2020 National Center for Health Research’s Public Comments on FDA’s Draft Guidance on Levonorgestrel [Docket Number FDA-2007-D-0369] We are pleased to have the opportunity to comment on the FDA Draft Guidance on Levonorgestrel IUD devices for the design of bioequivalence studies supporting abbreviated new drug applications. The National Center for Health Research (NCHR) is […]
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.
Here are our Statements and Positions on issues that affect you.
NCHR’s comments on FDA’s Draft Guidance for Industry on Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
The FDA’s draft guidance describes circumstances under which exceptions can be made to the requirement of two adequately controlled clinical trials. Although the law allows these exceptions under certain circumstances, we have concerns over the frequency with which these exceptions are made.
Read More »NCHR’s Comments on USPSTF’s Draft Research Plan for Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults Without Known Risk Factors
We support USPSTF’s efforts to update existing recommendations based on new research. Although we applaud many aspects of the draft research plan, it would benefit from including several additional analyses.
Read More »NCHR Signature on AB 1989 Opposition Letter
March 11, 2020. We oppose, unless amended AB 1989, the Menstrual Product Right to Know Act of 2020. Unlike cleaning products, less is known about the manufacture, ingredients and potential health impacts of menstrual products. People using menstrual products have the right to avoid exposures that will lead to allergic reactions.
Read More »NCHR Statement Supporting Maryland House Bill to Ban State Funds for Artificial Turf and Playgrounds
March 5, 2020. Officials in communities all over the country have been misled by artificial turf salespeople. They were erroneously told that these products are safe. But on the contrary, there is clear scientific evidence that these materials are harmful. The only question is how much exposure is likely to be harmful to which children? We should not be willing to take such a risk. Our children deserve better.
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