NCHR Testimony at the FDA about Type 2 Diabetes Drug, Semaglutide

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.

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