April 12, 2016. NCHR realizes that there is currently an unmet need for a drug to treat patients whose NSCLC has become resistant to first line TKI therapies via the T790M mutation. However, this does not warrant the approval of yet another drug that will not significantly improve outcomes for these patients. Fortunately, there is hope on the horizon, because the preliminary results for osimertinib for the same patients appears to be much more effective with fewer serious side effects.
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.
Establishing Paid Sick Leave for Federal Contractors
April 12, 2016. The federal government provides paid sick leave to its employees, but not those who work indirectly for the federal government as contractors. This rule would extend sick leave for an estimated 828,000 employees.
Read More »NCHR Testimony at FDA on Pimavanserin (Nuplazid) for Parkinson’s Patients with Psychosis
March 29, 2016. Because of concerns over the limited efficacy, the test used, and the high incidence of adverse events, NCHR urges FDA to not support the approval of pimavanserin [Nuplazid].
Read More »NCHR Supports Proposed FDA Regulation of Sunscreens
March 25, 2016. NCHR strongly supports the safety and effectiveness clinical and nonclinical testing requirements to obtain generally recognized as safe and effective (GRASE) status, as they are delineated in the draft guidance. The proposed testing requirements for new sunscreen chemicals will assure our country’s most vulnerable that the products will protect them from skin cancer and not cause unintended harm.
Read More »NCHR Comments on the Proposed Order Reclassification of Electroconvulsive Therapy Devices
March 28, 2016. Our review of the research indicates that ECT devices should remain as class III and should be subject to PMA review. The risks for patients associated with down classification of ECT devices for depression greatly outweigh any presumed benefit.
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