The FDA wants to get public feedback on its guideline for researchers interested in filing abbreviated new drug applications (ANDA) for CBD solutions. According to the agency, the new guidance for CBD medicines will make it easier to approve them.
The FDA stated that in order to speed up the acceptance process of the new CBD drug, applicants can ask for an in vivo bioequivalence review if their products meet several certain requirements stated in a new guide. This guide came out two years after the FDA approved GW Pharmaceuticals’ innovative CBD-based epilepsy drug Epidiolex.
In other words, this guidance allows a pharmaceutical company to produce new versions of an acceptable amount of a cannabidiol solution, it has to follow certain rules to avoid the in vivo bioequivalence review step. If the essential guidelines are complete, the company can request a renouncement of the review. The new essential guidelines require that the medicine must be based on Cannabis sativa L, contain only 0.1 percent THC, and have no prohibited ingredients or other formula changes (except those that are allowed) that could significantly affect systemic availability of CBD-based drugs.
Researchers and scientist that want to claim a new medicine should use proper analytical methods (for example macroscopic or microscopic analysis or DNA barcoding techniques) to determine that the solution contains allowed cannabis Sativa.