NCHR Comments on Quality System Regulation Amendments for Medical Devices

May 24, 2022. We recognize that the proposed harmonization with international consensus standard for devices would allow companies to have a single quality management system. However, the proposal ignores several issues of great importance to patients and consumers, and these issues deserve more attention as FDA considers changes to the proposed rule.

Read More »

NCHR Comments on Hormone Therapy in Postmenopausal Women for the Primary Prevention of Chronic Conditions

May 16, 2022. The currently available evidence on hormone therapy is very clear: Whether combination therapies of estrogen and progestin or treatments with estrogen alone, the risks by far outweigh the limited benefits for postmenopausal women. We thus strongly support USPSTF’s “D” grade recommendation against the use of combined estrogen and progestin for the primary prevention of chronic conditions such as cardiovascular disease, types of cancer, and osteoporotic fractures in postmenopausal persons, as well as the “D” grade recommendation against the use of estrogen alone in postmenopausal persons who have had a hysterectomy.

Read More »

NCHR Comments on EPA truck pollution standards

May 16, 2022. NCHR agrees with the Environmental Protection Agency (EPA) that the proposed truck pollution standards, which would reduce emissions of smog- and soot-forming nitrogen oxides, are a crucial step towards EPA’s commitment to climate, clean air and environmental justice. However, in light of the ongoing health and climate crisis, the proposed standards fall short of a zero-emission transportation future, and we urge EPA to further strengthen the proposed standards. This has also long been requested by environmental justice communities across the country, because while truck pollution has been devastating the health of communities across the country, it has a disproportionate impact on communities of color.

Read More »