FDA’s Big 5 Challenges - Webinar CD/Transcript

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FDA’s Big 5 Challenges: Agency Tackles Botox, Cannabis, Opioids, Tobacco Intended Use, Right-to-Try

The FDA likely will break new ground this year, posing extraordinary regulatory challenges to Rx, food and tobacco interests.

Botox. Cannabis. Opioids. Tobacco intended use. State right-to-try initiatives. How will the FDA tackle these hot potatoes? How will agency actions affect you?

Here’s your opportunity to peek behind the agency’s closed doors as it makes ready to enter uncharted territory. Join us for a first-ever look at the 5 hot-button issues that could affect the FDA’s direction — and your future:

  • Botox approvals:  Black box warnings, patents, scams, Botox® parties, legal implications, state actions ...
  • Marijuana regulation: Likelihood of regulation as a drug, “medical marijuana” and the FDA, synthetic marijuana regulation, state and local actions ...
  • Opioid Task Force:  How its actions could affect Rx drugmakers, potential new regulatory initiatives ...
  • The Intended Use Rule: How it might change during the Gottlieb tenure ...
  • Right -to-Try Movement: Gaining momentum or losing steam? And what will be the impact on pharmaceutical regulatory and quality operations?

Lawyer and author Roseann B. Termini Esq. is your guide. With more than 30 years of expertise in FDA regulatory areas including direct-to-consumer advertising and corporate accountability, she’ll fill you in on current FDA thinking and trends.

It’s a first-ever opportunity to prepare in advance for an extraordinary regulatory year. Don’t miss it.

  • Sales/Marketing
  • Strategic Planning
  • Product Developers
  • Regulatory Affairs/Compliance
  • QA/QC
  • Risk Managers
  • Product Assurance
  • Enforcement Staff
  • Scientists

Food and drug law expert Roseann B. Termini Esq. is an author, educator and advocate specializing in direct-to-consumer advertising and corporate accountability. As a lawyer she successfully litigated and prosecuted numerous cases involving food and drug law. As an educator she created online food and drug law courses at Widener University Law School. She is editor of the series Life Sciences Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods and Dietary Supplements and a founding board member of the Center for Pharmaceutical Health Services Research.