Weakness reported in FDA approval system for new cardiovascular devices HERE.
The drug approval path has always had such weaknesses, as well. Indeed it would be cost-prohibitive to conduct and await truly strong scientific analyses/screens of products in the medical pipeline. The pressure to opt for speed (and profit) in the process will always overwhelm the emphasis on safety. The solution is not to spend more time on better science, but to better communicate the potential risks and negative outcomes of treatments to consumers, moving toward an improved system of informed consent (medicine ought be consensual, not brow-beaten).
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