FDA’s New Labeling Requirements for Opioids

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
60 minutes
Product Description

Stay up-to-date with FDA’s regulations on Labeling Requirements for Opioids?


The United States Food and Drug Administration (FDA) is making an effort to educate patients/prescribers and ensure better communication for the potential risks of opioid use.  FDA Commissioner stated “Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids.”

In a continuing effort, the FDA recently announced requirements for safety labeling changes for opioid pain medications.

This conference is intended to discuss new labeling changes and FDA recommendations applicable for opioid pain medications.  It is further intended to present FDA pending actions for the opioid industry to stay compliant with the FDA recommendations and requirements. Join expert speaker David Lim, who through this presentation will provide great opportunities to become aware of and get familiar with FDA’s new requirements for opioid labeling changes. In this conference, David will discuss what firms should consider and implement the good practices compliant with the FDA’s recommendations so that FDA enforcement actions can be avoided.

Session Highlights

  • Applicable Laws and Regulations
  • Definitions
  • Opioids: IR and ER/LA
  • Opioid Safety Labeling Changes
  • New Safety Measures and Warnings for Opioids
  • Precaution Statements Required
  • Updated Labeling Requirements
  • Recent Safety Communication
  • Generic Opioids
  • Recent FDA Approvals for Opioids
  • PASS-IT Recommendations: Dos and Don'ts

Who should attend?

  • Healthcare Industry Professionals
  • Compliance Officers
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • Pharmacy and Compounding Industry
  • R&D Professionals
  • Consultants
  • Contractors/Subcontractors
  • Other professionals interested in this topic

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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