November 20, 2013. We welcome the opportunity to comment on the FDA’s guidance to industry on preclinical detection of endocrine disruption potential in drug and biologics applications.
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.
Comments on FDA Safety and Innovation Act Section 907 Report
November 20, 2013. The National Research Center for Women & Families strongly supports the requirement of the Food and Drug Administration Safety and Innovation Act (FDASIA) for an action plan to include demographic subgroups in clinical trials and data analysis.
Read More »Letter to FDA Regarding Advisory Committee Panel on Reclassification of CPR Devices
November 5, 2013. We write to express strong concerns about the September 11, 2013 FDA meeting of the Advisory Committee for Circulatory System Devices. This Advisory Committee meeting discussed and made recommendations regarding the proposed down-classification of External Cardiac Compressor (ECC) devices. The panel members were asked to consider the FDA recommendation that ECC devices be reclassified from Class III (high risk) to Class II (moderate risk) with special controls.
Read More »Patient, Consumer, and Public Health Coalition Comments on Requirements for Premarket Approval for Shortwave Diathermy for All Other Uses
October 4, 2013. We strongly support FDA’s proposed rule to classify the SWD for all other uses as a Class III device, which will require a PMA; we do not support a PDP for this device.
Read More »NCHR Testimony on Expanded Indications for Medtronic Cardiac Resynchronization Therapy Devices
October 8, 2013. We oppose the expansion of indications for Cardiac Resynchronization Therapy Devices. We urge FDA to require more testing to prove that the benefits of these devices outweigh the risks for these new indications in general and for particular demographic subgroups.
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