The United States Food and Drug Administration (FDA) recently expressed deep concerns over the growing epidemic of opioid dependence, overuse and abuse on families and communities.
Opioids as prescription drugs are used to reduce chronic pain. Opioids offer both great benefits and also serious risks, potentially causing serious harm (addiction, overdose and even death) when misused or abused.
This seminar is intended to help industry and professionals to better understand FDA roles and regulation governing controlled substances (opioids) used for pain management. This seminar is also intended to help industry get better familiar with FDA’s recent activity and regulatory expectations for drugs (opioids) including generic opioids and recent approvals for pain management.
The speaker will guide you through the details of FDA roles, regulations, generic opioids and recent FDA approvals for chronic pain management.
Areas Covered in the Session :
Applicable Laws, Regulations and FDA Guidance
Regulations Governing Controlled Substances
Abuse-Deterrent Opioid Medications
Opioid Misuse & Abuse
New Labeling Requirements
FDA Approved Opioids: Generics and ER/LA Opioids
Prevention of Opioid Abuse
Appropriate Pain Management
Speaker’s PASS-IT Recommendations: Best Practices
Who Will Benefit:
Research & Development
Anyone Interested in the Opioid and Pain Management