Christmas came early for cannabis research scientists. The U.S. Drug Enforcement Agency (DEA) decided to ease some of the regulatory requirements that had been imposed on those who were conducting FDA-approved clinical trials on cannabidiol (CBD).
“This is certainly a step in the right direction towards the development and proof of CBD as an empirically efficacious compound. These modifications will streamline the research process regarding CBD’s possible medicinal value and help to bolster existing scientific research and studies,” said Seth Yakatan, CEO of Kalytera. Kalytera is one of the leading research companies that is developing synthetic CBD (Cannabidiol) compounds for various ailments including Osteporosis, Prader-Willi Syndrome, and Obesity.
Since marijuana or cannabis is a schedule 1 controlled substance, researchers are subjected to very restrictive procedures in order to study the drug. Many states, patients, doctor’s groups and drug companies all desire more information regarding the effects of cannabis on various illnesses, but with difficult conditions placed on those trying to do the studies the results lag the demand.
The changes are meant to streamline the research process and help the existing scientific studies. The DEA has sent letters to those scientists affected by the decision that is in effect immediately.
Before the change, if a scientist realized they needed more CBD to complete their study, they had to request in writing a change to their DEA research registration. The process delayed the study as the paperwork wound its way through the bureaucratic approval process that included not only the DEA, but also the Food and Drug Administration.
With this new change, the researcher can request a waiver and upon approval, easily modify their study protocol. The waiver takes the place of the approval step.
The FDA and the DEA work together on cannabis. The FDA oversees drugs for medical use, but since cannabis is considered a controlled substance, the DEA has to step in with its oversight as well.
By Deborah Borchardt - Forbes/Dec. 24, 2015
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