Recent controversies of drugs granted accelerated approval have raised important questions about the evidence needed to determine whether the benefits outweigh the risks in the short-term or the long-term, and what can be done to improve the pathway.
Read More »On Health Policy
NCHR Comments on FDA Guidance for Lead Levels in Food for Babies and Young Children
March 27, 2023: NCHR comments on the new FDA standards for lead in food for babies and young children. Standards must be implemented as soon as possible and should be enforced.
Read More »NCHR Comments on the Use of Medical Device User Fees Collected by FDA
March 20, 2023: In a public comment, we explain our concerns about FDA’s plan to distribute user fee funding to non-governmental organizations to support premarket real world evidence (RWE).
Read More »NCHR comments on AHRQ draft review on the management of postpartum hypertensive disorders of pregnancy
NCHR agrees with AHRQ draft review designed to enhance care for women with postpartum hypertensive disorders of pregnancy. We are encouraged by the focus on the important issue of maternal mortality and look forward to seeing a meaningful response by policymakers.
Read More »Meeting of Patient, Consumer, and Public Health Coalition with Commissioner Califf and Key FDA Officials
March 1, 2023: As a leader of the Patient, Consumer, and Public Health Coalition, the National Center for Health Research scheduled a meeting at the FDA with Commissioner Califf and other key FDA officials to discuss accelerated approval, lab developed diagnostic tests, and improvements to FDA Advisory Committees.
Read More »