802: Is Your Med Spa Compliant? The Truth About Off-Label Use & FDA Regulations
In this crucial episode of Beauty Bytes, I sit down with Madison Dini, a powerhouse attorney at Michelman & Robinson who operates right at the intersection of science, medicine, and the law. We tackle the "Wild West" of modern aesthetics and the regulatory challenges facing practices today—from exosomes and polynucleotides to the controversial landscape of PDGF (platelet-derived growth factor).
Madison breaks down the critical difference between FDA approval of a product versus the medical board’s regulation of the practice of medicine, helping us understand where the lines are truly drawn . We discuss why taking legal advice from social media is dangerous, how to properly navigate off-label use, and the practical steps you need to take regarding malpractice insurance and informed consent to protect your business .
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