FDA Warning Letters are formal notifications issued when the FDA finds significant regulatory violations in areas like labeling, marketing, or manufacturing practices. While a warning letter itself is not an immediate penalty, ignoring it can lead to severe consequences, including product seizures, injunctions, or loss of approvals. Companies typically have 15 business days to respond with corrective actions. Proactive compliance, quality management systems, internal audits, and employee trai...| Cohen Healthcare Law Group | Healthcare Lawyers | FDA & FTC Law
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When it comes to healthcare law, few regulations are as critical and as complex as the Anti-Kickback Statute (AKS). This federal law prohibits the exchange of anything of value to induce or reward referrals of business to federal healthcare programs. In other words, if a healthcare provider offers or accepts any kind of kickback for […]The post AKS Safe Harbors appeared first on Cohen Healthcare Law Group | Healthcare Lawyers | FDA & FTC Law.| Cohen Healthcare Law Group | Healthcare Lawyers | FDA & FTC Law
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The Stark Law, also known as the Physician Self-Referral Law, is a federal statute that prohibits physicians from referring patients for certain designated health services (DHS) payable by Medicare to an entity with which the physician or an immediate family member has a financial relationship, unless an exception applies. The law is designed to prevent […]The post Does Stark Law Apply to Medicaid Patients? appeared first on Cohen Healthcare Law Group | Healthcare Lawyers | FDA & FTC Law.| Cohen Healthcare Law Group | Healthcare Lawyers | FDA & FTC Law
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Healthcare practitioners and healthcare entities can enter into corporate integrity agreements with the OIG (of HHS) to ensure compliance in return for continued participation in federal healthcare programs.| Cohen Healthcare Law Group | Healthcare Lawyers | FDA & FTC Law
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In today's video, we'll talk about the role of the medical director in a med spa, or an IV hydration clinic, or integrative medicine center wellness clinic. What happens when a healthcare venture tries to swap out one medical director and swap in another?| Cohen Healthcare Law Group | Healthcare Lawyers | FDA & FTC Law