New FDA guidance should help expand the CBD-based medicine market

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The federal agency is beginning to break down the barriers to a larger CBD market

It’s been more than two years since the country started running legal cannabidiol (CBD) operations through hemp; however, the industry started its growth before the regulatory federal agencies had time to set some ground rules for regulations. This has caused the market to experience some restrictions when it comes to how CBD products are advertised, among other things, but now it seems that the US Food and Drug Administration (FDA) finally completed a new draft of guidelines to help CBD-based medicines to get approval and can hit the market.

The agency published a notice on the Federal Register on Wednesday, explaining that it was beginning a period of asking public feedback to its latest draft that has been created for researchers who are interested in submitting Abbreviated New Drug Applications (ANDAs) for CBD solutions. The FDA also wants to be sure these processes are resolved within short time frames, so, to expedite the approval process, applicants can request a waiver of a set in vivo bioequivalence study, but this can be done only if they meet certain requirements.

Even if this draft is only now being published, the FDA already approved one CBD-based medicine almost two years ago, the CBD-based epilepsy medication Epidiolex from GW Pharmaceuticals. From now on, if a company wants to produce generic versions of the medicine, they could follow specific rules to skip the in vivo bioequivalence study step, but only when the guidance is finalized. Those requirements ask for the compound to be derived from Cannabis sativa L, contain no more than 0.1% of tetrahydrocannabinol (THC) and have “no inactive ingredient or other change in formulation from the [reference listed drug] that may significantly affect systemic availability.”