FDA ComplianceRegulations & Compliance

FDA opioid regulation reshapes chronic pain treatment with safer alternatives

This article explores the urgency behind FDA’s recent changes in Opioid regulation, the detailed policy framework, and its broad implications for healthcare providers, patients, and the pharmaceutical industry. Readers will gain insight into the evolving regulatory landscape, compliance demands, and future trends in chronic pain management.

HealthcareFDA ComplianceMed-Device ComplianceRegulations & Compliance

FDA Mental Health Chatbot Rules Tighten Amid Rising AI Risks and Hype

The FDA’s announcement, published in the Federal Register, highlights the “novel risks” posed by devices having Mental Health Chatbots and signals a shift toward more stringent oversight to ensure safety and efficacy. This article explores the implications of these regulatory developments, the evolving landscape, and what it means for companies and users alike.