Void · Condition unmet

The FDA approves midomafetamine (MDMA-assisted therapy) for post-traumatic stress disorder with labeling or a REMS that requires the drug to be administered under direct supervision in a certified healthcare setting and not dispensed to patients for use outside that setting.

TRUE on the date of an FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD, under any sponsor name, whose approved labeling or REMS document requires that each dose is administered in a certified healthcare setting under the supervision of a healthcare provider, and does not permit dispensing the drug to the patient for use outside that setting. FALSE on the date of an approval whose labeling or REMS permits a pharmacy to dispense the product to the patient for use outside a healthcare setting, or permits unsupervised use. The event is unresolved while no approval exists. Resolution source: Drugs@FDA (approved labeling) read with REMS@FDA.

Resolution source: Drugs@FDA (approved labeling) with REMS@FDA

Readings: 'Only be able to administer MDMA under direct supervision in clinic settings', 'not as a take-home drug but only for use in controlled therapeutic settings' and 'it will be approved only under direct supervision of therapists' name the same restriction.; 'Not like a normal drug that's approved' is the contrast with retail dispensing.; A REMS that certifies healthcare settings and requires monitoring during the session counts as 'direct supervision'; whether the supervising person is a licensed therapist or another healthcare provider does not change the reading.; The claim presupposes FDA approval of midomafetamine for PTSD; if no approval occurs in the window the condition is unmet and the item is void rather than scored.; E-0067 (retail-pharmacy dispensing for a psilocybin, LSD or MDMA product, class reading) is the mirror image on a wider asset; this entry is on midomafetamine alone, so that a psilocybin decision does not resolve it. The relation is logged for the registry.; Distinct from mdma-rems-sponsor-trained-therapists (who may administer) and mdma-approval-carries-rems (any REMS).