NCHR and the Patient, Consumer, and Public Health Coalition oppose the Promising Pathways Act, which would allow FDA to approve drugs that aren’t proven to work and then to remain on market for up to 8 years without proof of effectiveness. The bill is supposed to help provide treatment for the most serious diseases, but is poorly written, providing false hope, huge financial burdens for patients and Medicare, and undermining existing FDA pathways that are more targeted to urgently needed treatments.
Read More »On Health Policy
Public Comment of the National Center for Health Research on USDA Proposed Rule on New Program on Natural Grass and Sod Products, Docket AMS-LP-21-0028
December 15, 2023: In response to a request for public comment, NCHR submitted a comment in support of the USDA proposed rule to establish a promotion, research, and information program for natural grass sod products. We believe this will provide important information that will help reduce the proliferation of artificial turf, which endangers the health of children and adults as well as harming the environment.
Read More »NCHR’s Comment on the ATF’s Proposed Rule on the Definition of “Engaged in the business”
December 5, 2023: NCHR supports the ATF’s proposed rule that will implement an updated definition of “engaged in business” so that anyone engaged in selling firearms “for profit” will be deemed as sellers required to do background checks on their patrons. This new rule will require trade shows and online retailers to be regulated the same as brick-and-mortar establishments.
Read More »Patient, Consumer, and Public Health Coalition Comments Regarding the FDA Draft Guidance Recommendations for Evidentiary Expectations for 510(k) Implant Devices
December 6, 2023: In its public comment, members of the Patient, Consumer, Public Health Coalition urged FDA to institute stronger standards to determine clinically meaningful substantial equivalence for 510(k) clearance.
Read More »Patient, Consumer, and Public Health Coalition Comments Regarding the FDA Draft Guidance Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions
December 6, 2023: In its public comment, members of the Patient, Consumer, Public Health Coalition urged FDA to rely more on scientifically credible types of clinical data for 510(k) to ensure patients’ health and safety.
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