For Psychedelics, US FDA Is Open To Creative Thinking But Firm On Approval Standards

 
• By Bridget Silverman
  
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Flexible thinking and rigorous standards will both be needed to develop psychedelics as drug therapies in order to surmount the many complicating factors, from unique ‘set and setting’ aspects to functional unblinding, speakers at Reagan-Udall Foundation meeting agree.

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Psychedelic drugs present unique challenges to the conventional drug development paradigm, so it is fitting that a more unconventional or creative package of clinical trials could make for a more successful NDA than the traditional ideal of two replicate randomized pivotal trials.

Key Takeaways

  • From dose response to maintenance assessment, trials for psychedelic drugs will likely be very different from other psychiatric drugs, even if the approval standards are the same.

“Our regulations are inherently flexible, and the exact types of studies that are needed to provide this data aren’t specified,”...

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