November 16, 2021: There are issues of safety and effectiveness in the GDUFA III Commitment letter.
Read More »On Health Policy
NCHR’s Comments on USPSTF’s Draft Recommendation Statement on Screening for Eating Disorders
November 15, 2021: We strongly agree with the USPSTF’s “I” grade recommendation that there is insufficient evidence in order to assess the benefits and risks of universal screening for eating disorders in asymptomatic adolescents and adults.
Read More »NCHR’s Comments at EPA’s 2021 CHPAC Meeting
November 2, 2021: We strongly urge the EPA to conduct research on how currently used materials for artificial turf and playgrounds can pose risks to the health of the children who play on them, and to develop standards to regulate the safety of these materials.
Read More »Testimony of Dr. Diana Zuckerman, NCHR, at the FDA PDUFA Meeting, September 28, 2021
September 28, 2021: After reviewing FDA’s PDUFA VII plans, I have concerns about the performance goals and policies that the FDA has negotiated with industry behind closed doors.
Read More »NCHR’s Comments to FDA on the Remanufacturing of Medical Devices
September 22, 2021: We agree with the FDA that clarification is needed of whether or not activities performed on medical devices are considered “remanufacturing” or “servicing,” and we support the draft guidance’s clarity on how to correctly classify a procedure.
Read More »