October 18, 2017. In summary, we urge this Committee to recommend that the sponsor re-analyze the existing data to determine whether the benefits outweigh the risks for women of color, white women, men and women over 65, and other major demographic groups. We also recommend a longer follow-up of patients in the studies to determine safety, including appropriate evaluation of diabetic retinopathy. If there are too few patients in major subgroups to meaningfully evaluate risks and benefits, the sponsor should be required to add patients prior to FDA making a decision about approval. We urge this Committee to consider the safety and efficacy of Semaglutide within demographic subgroups and not subject patients to uncertain risk.
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NCHR Comments on the USPSTF’s Draft Research Plan for Hepatitis C Virus Infection in Adolescents and Adults: Screening
October 18, 2017. The USPSTF proposes a plan to review research and evidence on the benefits and harms of Hepatitis C virus screening in adults and adolescents. Our Center supports the efforts of USPSTF to reassess the merits of broad screening programs. We offer additional suggestions for an analysis plan that will inform future recommendations and best practice guidelines on this most important issue.
Read More »NCHR Comments on the USPSTF Draft Research Plan for Asymptomatic Bacteriuria in Adults: Screening
Not all bacteria is bad, and we don’t have to treat everything we detect. We urge the USPSTF to consider the new evidence for or against broad screening.
Read More »NCHR Comments at CDRH’s Voluntary Medical Device Manufacturing and Product Quality Workshop
October 10, 2017. Recalls demonstrate the crucial need for improved medical device quality, and for more clinical testing of such devices before they are put onto the marketplace, as well as improved inspections of manufacturing facilities prior to them going on the market. It’s a positive sign that this pilot program will address at least some of these inspectional issues.
Read More »NCHR Comments on the USPSTF’s Draft Recommendation Statement, Evidence Review, and Modeling Report on Cervical Cancer Screening
October 9, 2017. The USPSTF proposes new cervical cancer screening recommendations. Surprisingly, the USPSTF proposes eliminating co-testing (pap and HPV test together) as a preferred screening approach in favor of the HPV test alone. Do the proposed recommendations deserve an “A” rating? Read our comments to find out.
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