Simplifying Global Compliance
Four Hot Topics in FDA Regulation & Compliance - Webinar Recording/Transcript
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Four Hot Topics in FDA Regulation & Compliance: Opioids, Biosimilars, Right-to-Try and Dietary Supplements
There’s the opioid initiative and the FDA’s opioid task force. There’s right-to-try, biosimilars and dietary-supplement regulation. And host of other changes from the FDA, Congress, the White House and even on the state level.
Join noted FDA legal scholar Roseann B. Termini Esq. for the real skinny on four top issues. You’ll discover everything you need to know … in just 90 minutes.
Presentation Takeaways:
- Trump’s opioid initiative: How goes the crackdown on Rx firms and opioids?
- FDA opioid task force: Initiatives to combat the opioid epidemic
- Right to Try and S. 204: Where does guidance on the new law stand?
- Dietary supplement regulation: Food? Drug? Something new?
- Biosimilar Development and the BPCI Act (Revision 2) Guidance: Nuances of the new-and-revised draft Q&As
From drugs to biotech, devices to diagnostics, every FDA-regulated player could do with a crystal ball. We offer the closest thing.
- Executive suite
- Strategic planning
- Marketing/advertising/sales
- Quality/QSR
- Regulatory affairs
- Research & development
- Postmarket safety
- Commercial operations
- Legal counsel
Roseann B. Termini Esq. boasts 30+ years practicing food and drug law. She’s also a respected author and commentator and first-ever winner of the Plain English Award. Her 12-volume handbook series Food & Drug Law is now in its tenth edition. She initiated the inaugural online food and drug law courses at Widener University School of Law and direct-to-consumer promotion at St. Joseph’s University executive program. With a legal career that started with an appellate clerkship and has encompassed both government and private-sector work, she sees food and drug law from all sides.
