March 19, 2012. The National Research Center for Women and Families has been a long-time advocate of medical device clinical studies including data on safety and effectiveness for women. In this comment letter to the FDA, we describe the importance of analyzing data for women separately and how this information should be used to help women and providers make the best informed decisions.
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 Testimony in Support of the Ensuring Safe Medical Devices for Patients Act
March 15, 2012. Paul Brown, NRC’s Government Relations Manager, released a statement supporting Senator Merkley’s bill, “Ensuring Safe Medical Devices for Patient Act” that requires the Food and Drug Administration (FDA) to establish a Unique Device Identifier (UDI) rule by the end of year and add medical devices to the Sentinel system.
Read More »Letter to Dr. Hamburg, FDA Commissioner on the Review of Drospirenone (DRSP)-Based Oral Contraceptives
March 9, 2012. When oral contraceptives first became available, comparing risks and benefits of oral contraceptives to pregnancy was the right question.
Read More »Letter from the Patient, Consumer and Public Health Coalition to Dr. Margaret Hamburg on the De Novo Process and High-Risk Medical Devices
February 28, 2012. In this letter to the FDA Commissioner, the Patient, Consumer, and Public Health Coalition expresses their concerns over the de novo approval process for high-risk medical devices, specifically a endovascular suturing system.
Read More »NCHR Testimony on Classification for Cranial Electrotherapy Stimulators
February 10, 2012. This testimony supported the FDA’s position that the available scientific evidence does not support reclassifying Cranial Electrotherapy Stimulators to a medical device category with lower risk.
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