NCHR Comments on FDA’s Draft Guidance on Post-Market Studies and Clinical Trials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.

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