December 8, 2021: We agree with FDA scientists that bardoxolone does not demonstrate effectiveness at slowing the loss of kidney function and reducing the risk of progression to kidney failure, which are the outcomes that matter most to patients.
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NCHR’s Testimony to FDA About Molnupiravir for COVID-19
November 30, 2021: For molnupiravir, the balance of benefits and risks may differ between different types of patients, and not all types of patients were studied.
Read More »NCHR Comments on USPSTF’s Draft Recommendation on Aspirin Use to Prevent Cardiovascular Disease
November 8, 2021. Based on the data, we strongly support the “C” grade recommendation for patients 40 to 59 years old with a 10% or more risk of developing CVD, as well as the “D” grade recommendation for patients 60 and older. However, we urge the USPSTF to include additional information to their recommendation.
Read More »NCHR’s Testimony at FDA’s November 3, 2021 Circulatory Systems Devices Advisory Committee Meeting
November 3, 2021: We are concerned about the conflicting data on EVAR devices, and the reliance on 5-year studies that include different iterations of a device.
Read More »NCHR’s FDA Advisory Committee Testimony on Carbetocin Nasal Spray for Hyperphagia in Prader Willi Syndrome
November 4, 2021. NCHR agrees with FDA criticisms of the evidence. Families urgently need help, but the company should spend a few more months to establish whether this drug is effective and safe for more than 8 weeks – BEFORE FDA considers approving it.
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