Regulatory Blog

The U.S. Food and Drug Administration (FDA) continues to expand its regulatory focus on safer pain management, opioid risk reduction, addiction treatment innovation, and infectious disease drug development through multiple recent guidance documents. These guidances collectively highlight the FDA’s evolving strategy toward: Reducing opioid dependence Encouraging non-opioid therapies Supporting innovative pain treatments Strengthening benefit-risk assessments Advancing addictio

The U.S. Food and Drug Administration (FDA) has released a new draft guidance " Development of Non-Opioid Analgesics for Chronic Pain "...