NCHR Testimony on the Opioid Oliceridine

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.

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NCHR Comments on FDA’s Draft Guidance on Patient-Focused Drug Development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.

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