NCHR Author

NCHR Testimony at FDA at the Circulatory System Devices Panel Meeting

NCHR testified at the FDA circulatory system device panel meeting to urge the committee to hold hypertensive devices to a better standard

NCHR Comments on the USPSTF Draft Recommendation Statement for Human Immunodeficiency Virus (HIV) Infection Screening

We enthusiastically support the efforts of the U.S. Preventive Services Task Force (USPSTF) to re-evaluate its recommendations as new research emerges. We strongly agree with the USPSTF recommendation that clinicians screen adolescents and adults ages 15 to 65, as well pregnant women during their prenatal period or when they present in labor or at delivery and their HIV status is not known.

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.

NCHR Comment on FDA’s 510(k) Third Party Review Program Draft Guidance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.

NCHR Testimony at the FDA on Optimizer for Heart Failure

December 4, 2018. We all want to help these patients, but new treatments need to provide a real benefit. The questions that we need to answer are does this device help patients and should patients continue to have the option of receiving an experimental treatment as part of a clinical trial, or should they pay for an experimental treatment that has been described as a breakthrough?