January 6, 2020. The draft document describes how FDA staff evaluates postmarket safety surveillance but lacks some essential information about FAERS, post-marketing studies, the Sentinel Initiative, and safety signal resolution.
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NCHR Comments FDA’s Draft Guidance on Clinical Decision Support Software
December 23, 2019.We appreciate FDA clarifying plans for regulating Clinical Decision Support (CDS) software; however, we have concerns regarding the draft guidance.
Read More »NCHR’s Comments on FDA’s Proposed Rule on Tobacco Product Applications
December 16, 2019. FDA’s proposed requirements for premarket tobacco product applications (PMTAs) defines the extent to which FDA is able to thoroughly evaluate the potential health effects of these products on consumers and, in particular, vulnerable populations such as children and adolescents.
Read More »NCHR Comments on FDA’s Draft Guidance on Post-Market Studies and Clinical Trials
December 20, 2019. Post-market clinical trials and other studies can help inform FDA and the public about the risks and benefits of medical products. However, when they are relied upon to answer questions better addressed prior to approval, or if less effective studies or trials are used, or if studies are delayed and inadequate, they do not provide the intended data that is needed by FDA, patients, and healthcare providers. This adds to the already high cost of medical care.
Read More »NCHR’s Comments on the Safer Technologies Program (STeP) for Medical Devices
November 18, 2019. We therefore respectfully urge the FDA to revise the proposed guidance in ways that ensure that all medical devices undergo more rigorous testing prior to being approved or cleared.
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