The Evolution of REMS: FDA Risk Management Considerations for Novel Risks Associated with Psychoactive Drugs

• Understand how FDA thinking around REMS requirements for psychedelics and other novel therapies is evolving.
• Learn what factors FDA considers when determining whether a REMS is necessary.
• See how sodium oxybate and esketamine can provide useful precedent for emerging therapies.
• Understand how FDA evaluates risk management strategies during development and review.
• Learn how to prepare for more productive FDA and pre-NDA REMS discussions.

• How FDA thinking around REMS requirements has evolved for therapies with histories of recreational or non-medical use
• The factors regulators consider when determining whether a REMS is necessary
• How precedent REMS programs may inform future requirements for emerging therapies, including psychedelics
• The FDA’s internal process for evaluating risk management strategies during development and review
• What sponsors can do during development and pre-NDA interactions to support productive REMS discussions

REMS for Drugs with Histories of Recreational Use

Products such as sodium oxybate and esketamine entered the prescription market with significantly different risk management approaches despite sharing certain risk considerations. We’ll discuss how FDA’s focus appears to be shifting beyond traditional concerns about abuse potential and diversion, and how emerging therapies may be evaluated through the lens of patient impairment, altered mental status, and safe use conditions.

Understanding the Rationale Behind REMS Requirements

Why do some products associated with significant cognitive or perceptual effects receive a REMS while others do not? We’ll explore the factors FDA considers when assessing whether a REMS is necessary and the distinctions between products that ultimately receive one and those that do not.

FDA Engagement During Development and Review

Sponsors often struggle to understand when and how FDA risk management teams become involved throughout the review process. This discussion will provide greater visibility into the FDA’s approach and highlight opportunities for productive engagement before NDA submission.

Who Will Benefit From Attending?

This webinar is designed for professionals involved in:

• Regulatory Affairs professionals
• Drug Safety and Pharmacovigilance
• Clinical Development
• Regulatory Strategy
• Risk Management and Compliance
• Medical Affairs
• Quality and Governance
• Sponsor Teams Developing CNS, Psychiatry, or Emerging Therapies
• Organizations Preparing for NDA Submission

Is this webinar available on demand?

Yes. Register to access the webinar anytime.

Who should attend?

This session is ideal for regulatory, safety, clinical development, and compliance professionals involved in products that may require complex risk management strategies.

What practical insights will I gain?

You’ll gain a deeper understanding of FDA REMS decision-making, learn how to better prepare for regulatory discussions, and hear practical considerations for implementing and maintaining successful REMS programs.

Is there a cost to attend?

No. Registration is complimentary for all attendees.