2001 DEA Safety 
Veriheal
JUNE 26, 2025
Drug company Lykos Therapeutics, which had filed the new drug application for MDMA therapy , was informed by the US Food and Drug Administration (FDA) that the data submitted was insufficient to receive approval, requesting that the company conduct an additional Phase 3 trial to further test the safety and efficacy of the drug.
Cannabis Law Report
APRIL 8, 2022
Later that year, Doblin sued the DEA for the first time. The FDA formally decided to open the door to psychedelic research in human participants, and later accepted MAPS’ Phase 1 MDMA safety and tolerance study protocol. submitted his first DEA application to manufacture marijuana for use in medical research.
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CannaMD
SEPTEMBER 10, 2020
This creates a somewhat confusing landscape for mothers who might benefit from cannabis-based therapies, but are also concerned for the safety of their child and the very real possibility of institutional intervention when marijuana use during pregnancy is documented. But despite these revelations, both messaging and legalities have lagged.
Cannabis Law Report
MARCH 25, 2019
The DEA has made previous requests–in 2001 and 2006–to the FDA for an evaluation of marijuana. But DEA regulators determined after both of those reviews that marijuana should remain a Schedule I substance. 26, 2001 , 115 Stat. 26, 2001 , 115 Stat. 106–569, title VII , § ? 709(a), Dec. 3018 ; Pub.
Veriheal
FEBRUARY 1, 2021
The filing is backed by MAPS (Multidisciplinary Association for Psychedelic Studies) and calls on the DEA to answer a four-year-old filing requesting approval of his application to become a federally registered marijuana cultivator. Back in 2016, the DEA said they were starting the process of approving “additional marijuana cultivators.”
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