This webinar has been rescheduled to Thursday, May 7 at 2:30 p.m. PT. If you previously registered, you are still confirmed—no additional registration is needed. Please be sure to update your calendar accordingly. If you have not registered yet, you can do so using the link above.
The Psychedelics Executive Order: Navigating Dual Pathways to Market Access
One executive action just rewrote the rules for psychedelic medicine in America, and the companies that move the fastest will define the next decade of mental health treatment. On April 18, 2026, President Trump signed an executive order that fundamentally transforms how psychedelic medicines can reach patients in the United States. This 60-minute webinar will decode two regulatory pathways created by this landmark policy directive.
- Section 2(a) – Commissioner’s National Priority Vouchers (CNPVs): Discover how pharmaceutical companies with breakthrough therapy designation can compress FDA approval from 10 months to just one or two months. We’ll examine eligibility requirements, the track record of 12 vouchers already awarded, operational readiness demands (manufacturing scale-up, DEA coordination), and strategic considerations for companies pursuing ultra-fast approval.
- Section 2(b) – Right to Try Expansion: Learn how the executive order expands the federal Right to Try Act to Schedule I psychedelics for the first time in U.S. history. We’ll analyze the “life-threatening” condition interpretation for serious mental illness with suicide risk, the novel DEA “treating physician” authorization category, anticipated eligibility criteria, implementation timelines, and practical challenges for all stakeholders.
Whether you’re preparing an NDA submission, designing an expanded access program, developing hospital RTT policies, seeking treatment for a life-threatening condition, or guiding clients on regulatory strategy, this webinar will provide you with actionable intelligence as these pathways become operational.
Note: This webinar will offer educational analysis—not legal or medical advice. Consult qualified counsel for organization-specific guidance.
Presenters
Kimberly I. Chew, Attorney
Odette Hauke, Principal Consultant, Global Regulatory Affairs, Odette Alina, LLC
Karen Luong, Partner
Who Should Attend
Pharmaceutical and biotech executives; legal, regulatory, and compliance professionals; clinical development, R&D, and manufacturing leaders involved in psychedelic trials; healthcare system leaders and clinicians treating serious or treatment resistant mental health conditions; academic researchers and institutions; investors and life sciences analysts; policymakers and regulators; and organizations supporting the development of psychedelic medicines
Continuing Education Credit
This program is pending approval for California, Colorado, Illinois, Iowa, Kansas, Missouri, Minnesota, Nebraska, Pennsylvania, Tennessee, Texas, and Wisconsin continuing legal education credit.
Did you miss the webinar?
The webinar recording is available after the event date. Simply register using this on-demand link to access the recorded program.
Questions?
Contact Cilla Montgomery at 512.370.3457.