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Ropes & Gray LLP

FDA Makes Good on Promise to Publish CRLs for Unapproved Drugs and Biologics

Ropes & Gray LLP on

On September 4, 2025, the U.S. Food and Drug Administration (“FDA”) announced plans to begin releasing complete response letters (“CRLs”) “promptly” after it issues them to sponsors, rather than waiting until after approval....more

Bradley Arant Boult Cummings LLP

Crank the Party Up: Is the DEA About to Get It On with Psilocybin?

On August 11, 2025, the U.S. Drug Enforcement Administration officially transmitted a request to the Department of Health and Human Services to loosen the federal restriction on psilocybin, seeking to move one of the...more

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