December 23, 2019. We are urging that the FDA require a black box warning and Patient Informed Consent Check List that provides information about the risks of cancer, breast implant illness, and other serious health problems in explicit and easy-to-understand wording that all individuals considering breast implants can understand, regardless of educational level or stress that is inevitable when a person is considering surgery.
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NCHR Comments on FDA’s Draft Guidance on Post-Market Studies and Clinical Trials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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