August 16, 2018. Protecting the public health requires that EPA’s draft guidance for applying a systematic review process for risk evaluations is scientifically valid, reliable, and accepted by the scientific community. It should consider the totality of the scientific evidence without often irrelevant or industry-centric requirements that would reduce the impact of high quality sources or exclude them.
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’s Limited Population Pathway for Antibacterial and Antifungal Drugs
August 13, 2018. Everyone agrees that there is a need to develop new antimicrobials to treat serious or life-threatening infections. The only way to make sure that new drugs are safe and effective is by requiring well-designed and valid clinical trials.
Read More »NCHR Testimony on Amikacin Liposome Inhalation Suspension (ALIS) in Nontubercuolous Mycobacterial (NTM) Lung Disease
August 7, 2018. NCHR testimony of Amikacin Liposome Inhalation Suspension in Nontubercuolous Mycobacterial Lung Disease in regards to safety and efficacy.
Read More »NCHR Testimony on Omadacycline for Skin Infections and Pneumonia
August 8, 2018. If omadacycline is no better than some drugs on the market, and may be less safe or less effective for older patients, those with more serious infections, and patients with diabetes and lung disease, it is important to conduct further studies to know whether they should be excluded from the indication or not.
Read More »NCHR Testimony of TIRF REMS
August 3, 2018. TIRFs provide important options for cancer patients dealing with pain. However, we all know that they carry very serious risks and that’s why we need REMS that protect patients’ these risks. These REMS are not working as well as the should to protect patients and need to be approved.
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