such as oncology - Geunim

Navigating FDA Off-Label Use: Prescribing & Promotion Law

Meta Description: Understand the complex legal landscape of FDA Off-Label Use. We break down the crucial distinction between a healthcare provider’s freedom to prescribe and a manufacturer’s strict prohibition on off-label promotion (misbranding), including risks under the False Claims Act and recent commercial speech guidance. The practice of medicine often moves faster than the regulatory […]

Commercial Speech, Drug, drug misbranding, False Claims Act, FDA Off-Label Use, massive civil fines, misleading, non-misleading, Off-label marketing, patient population, pay, risks, safe, solicit, such as oncology