October 11, 2018. There are many unanswered questions about what dosages work and are safe for which patients under which conditions. We all know that is an epidemic of opioid use, so these questions must be answered before a decision is made about whether or not to approve oliceridine.
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NCHR Testimony on WEB Aneurysm Embolization System
September 27, 2018. There are important aspects of the clinical trial that make it difficult to determine if the WEB device is effective and safe for the indicated population. If the FDA does not demand better research, patients and their physicians may never know the answers to those questions.
Read More »Are Medical Devices Studied on “Whites Only?” Do We Know What Works for Which Patients?
Are these high-risk implants studied on Whites only? Mostly younger white men? Groundbreaking study of high-risk medical devices finds lack of information for patients who are women, people of color, and over 65 years of age.
Read More »NCHR Comments on FDA’s Draft Guidance on Patient-Focused Drug Development
September 11, 2018. We support FDA’s efforts to increase patient engagement and input into medical product development and testing. However, we recognize how challenging it is to ensure that the information will reflect the views and experiences of a representative sample of patients. That challenge must be met in order to develop treatments that have a more meaningful impact on patients’ lives with risks that patients consider acceptable.
Read More »NCHR’s Comments to EPA on Problem Formulations for Risk Evaluations under TSCA for Ten Chemicals
August 16, 2018. We oppose the EPA’s proposed “problem formulations” because they would not adequately evaluate exposure, harm or risk. They would exclude many of the uses, exposures, and hazards that would have been included in the risk evaluations that were planned as part of the scoping documents.
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