Posted by Hugh on March 27, 2024, at 13:59:20
In reply to The successful Phase 3 trial was published 5mo ago, posted by TriedEveryMedication on March 27, 2024, at 9:52:15
MAPS applied for FDA approval of MDMA in December.
MDMA should receive FDA approval in August.
It's been a maddeningly slow process. MAPS was founded in 1986 by Rick Doblin, and received approval for its first MDMA clinical trial in humans in 1992.
It took the DEA hardly any time at all to classify MDMA a Schedule I drug. The DEA's own administrative law judge concluded that MDMA should be a Schedule III drug, but the DEA overruled his decision and instead made MDMA a Schedule I drug -- the same as heroin.
https://academic.oup.com/book/46625/chapter-abstract/410053164
Rick Doblin said that a change of staff at the FDA has helped in moving along the MDMA clinical trials and approval process.
https://www.youtube.com/watch?v=c52BNcmMlK8
> How many years will the DEA/FDA drag their feet in approving this?
poster:Hugh
thread:1122346
URL: http://www.dr-bob.org/babble/20230117/msgs/1122355.html