January 11, 2019. NCHR authored a letter to senators regarding the effects of the government shutdown on the FDA and, therefore, patient safety.
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NCHR Comments on Prescription Drug-Use-Related Software
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.
Read More »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Read More »NCHR Comment on FDA’s 510(k) Third Party Review Program Draft Guidance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.
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