July 13, 2015. MDUFA should protect the public health by improving the safety and efficacy of all medical products, whether PMA or 510(k).
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 Position regarding the House of Representatives Passage of the 21st Century Cures Act
July 10, 2015. NCHR President Diana Zuckerman discusses how the 21st Century Cures Act undermines undermine scientific evidence used to approve medical products.
Read More »NCHR Testimony at FDA Advisory Committee on Cholesterol Drug Alirocumab
June 9, 2015. We are asking you to reject approval of this drug for women and people of color until and unless subgroup analyses indicate the benefits outweigh the risks for those populations.
Read More »NCHR Testimony Before FDA Advisory Panel on Flibanserin
June 4, 2015. The Center strongly supports research to advance understanding of, and solutions to, women’s lack of sexual desire. We understand that it is a real and distressing problem for many women. We have followed the regulatory history of flibanserin. Based on our analysis of the study results available today, we conclude that the benefits of this drug do not outweigh the risks. We ask the Advisory Committee to vote against approval of this drug.
Read More »Comments to the U.S. Consumer Product Safety Commission on Corded Window Coverings
June 1, 2015. We submit these comments in strong support of the U.S. Consumer Product Safety Commission’s (CPSC) development of a mandatory standard that prohibits hazardous, accessible window covering cords. A mandatory standard is needed because the current voluntary standard, which relies on warnings, has not significantly reduced the death rate.
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