December 20, 2022: We disagree with the guidance because of the enormous loophole it represents. Altering the eligibility criteria for the breakthrough pathway to include certain devices that have the “potential” to benefit certain populations is too vague. FDA must Improve the standards of evidence required to authorize Breakthrough medical devices prior to focusing on equity issues.
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NCHR Letter to Senate HELP and House Energy & Commerce Committees Regarding the VALID Act
December 14, 2022: We strongly support the inclusion of the VALID Act in the year-end omnibus spending package. This important bill will provide the FDA with the authority and resources necessary to ensure that the highest-risk diagnostic tests are valid and reliable.
Read More »NCHR encourages WSPI to do more to prevent long-term impact of diabetes in pregnancy
December 8, 2022: The National Center for Health Research (NCHR) agrees with the Women’s Preventive Services Initiative (WPSI) 2022 recommendations for diabetes screening after pregnancy. WPSI encourages continued diligence during the postpartum period in patients who were diagnosed with diabetes mellitus during pregnancy. That’s important because gestational diabetes increases a patient’s chances of developing type 2 diabetes.
Read More »NCHR Comments on EPA Request for Information on Better Indoor Air Quality (IAQ) Management to Help Reduce COVID-19
December 5, 2022: Current IAQ standards are insufficient and poorly regulated at state and local levels to keep the public safe from increased COVID-19 transmission and other respiratory illnesses. Federal mandates would ensure that all indoor public spaces are properly assessed to improve ventilation rates. In the absence of greater regulation, the EPA must promote alternative methods of air filtration such as the Corsi-Rosenthal Box.
Read More »National Center for Health Research (NCHR) Comment on FDA proposed ruling for ACNU Nonprescription Drug Products
November 25, 2022: We appreciate the FDA’s interest in establishing requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). However, the FDA has not identified a mechanism to ensure appropriate use. Based on our experience with patients across the country, we believe it would be impossible to do so. For that reason, we do not support the proposed ruling.
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