Day: July 16, 2026

Bringing a molecule like psilocybin or MDMA to the commercial market is unlike any traditional drug development journey. In its guidance document, the FDA is proving a long-awaited regulatory map to describe how developing these drugs mirrors conventional drug development, and where it chart-starts entirely new territory. At their core, psychedelic drug programs are not exempt from the golden standards of modern medicine. The FDA makes it clear that … Read more

Navigating the labyrinth of FDA regulations often feels like learning a highly specialized dialect of a language you only half-understand. With the release of the July 2026 guidance on formal meetings for Over-the-Counter (OTC) monograph drugs, the agency has introduced a brand-new vocabulary of Type X, Y, and Z meetings. While these terms might sound like characters in an … Read more