FDA Guidelines to Enable CBD-Based Medicine Approval
A new draft guideline is scheduled for release by the Food and Drug Administration (FDA) that aims to simplify approvals for oral CBD meds.
The guidelines come some two years after the FDA approved GW Pharmaceuticals’ Epidiolex — a CBD epilepsy medication. The main goal of the draft is to help companies streamline the entire approval process. That said, applicants, who meet the specified requirements, can request a waiver for in vivo studies.
With the introduction of the draft, applicants who want to create a generic CBD solution could use the guidelines to bypass the procedure altogether. But only in the case of medication that is a Cannabis sativa L-based derivative with a THC concentration lower than 0.1%.
In addition to that, it’s clear that the final compound should not have any formulation changes or inactive ingredients that might interfere with the systemic availability of the medication.
Also, during research, experts should stick to strict analytic processes, such as detailed micro- or macroscopic examination, and/or DNA analysis to help establish whether the final product is actually made from the right derivative or not. While gathering the raw materials for the process, applicants must stick to appropriate GACP procedures, as well as the highest possible standards, to ensure that the drug remains consistent with each batch.
Despite this document not being groundbreaking for the industry (as experts say), it’s still a good example of how the general consensus regarding cannabis is slowly but surely changing in scientific circles.