January 10, 2019. Digital Health is a new area of healthcare covering a broad set of technologies with diverse applications in healthcare. The proposed risk-based framework provides an important foundation for prescription drug-use-related software, but several important issues remain.
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NCHR Comment on USPSTF Draft Recommendation Statement for Prevention of HIV: Pre-Exposure Prophylaxis
December 20, 2018. In summary, we support U.S. Preventative Services Task Force’s draft recommendation on the use of pre-exposure prophylaxis for high risk populations.
Read More »NCHR Comment on FDA’s 510(k) Third Party Review Program Draft Guidance
December 13, 2018. The third party review program clearly moves in the opposite direction, reducing patient safety, rather than protecting patients from potentially harmful devices. We strongly oppose it for that reason.
Read More »NCHR Testimony to the FDA Patient Engagement Advisory Committee on Medical Devices
November 15, 2019. NCHR testified to the FDA regarding social media surrounding medical devices, and how it affects patient engagement.
Read More »NCHR Comments on FDA’s Draft Guidance on Patient-Focused Drug Development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.
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