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Psychedelic Drugs: Regulators Still Unsure On Development Path, But Willing To Listen

 
• By Derrick Gingery

Potential sponsors have many questions to answer, but have a unique opportunity to influence policy for a new therapy area.

mushrooms
An EMA official said sponsors may have to think out of box in designing psychedelic clinical trials. • Source: Shutterstock

Psychedelic drug development may no longer be impossible or unlikely, but basic clinical questions still must be answered to help unleash the sector’s growth.

After decades on Schedule I, the US Food and Drug Administration and other regulators have recognized that psychedelics like LSD may have clinical benefits. Guidance now is available to help...

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More from Conferences

EU HTA Regulation: ‘Stepping Beyond’ JCAs May Be Needed For Very Rare Disease Drugs

 
• By Francesca Bruce

Cooperation between health technology assessment bodies across the EU will lead to a better joint clinical assessment process over time, but patients cannot afford a lengthy wait for improvements, speakers at a cell & gene therapy conference said.

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How States And Courts Could Insulate America From An Anti-Vaccine Executive Branch

 
• By Sarah Karlin-Smith

The mood at the World Vaccines Congress in Washington, D.C. was bleak given Robert F. Kennedy Jr.’s rise to lead the Trump Administration’s Health and Human Services Department, but vaccine lawyers offered an optimistic outlook and ideas for countering his vaccine agenda.