The FDA holds virtual biotech companies accountable for the clinical trials they sponsor. If a…
The Food and Drug Administration (FDA) recently approved a widely known Cannabidiol (CBD) drug, Epidiolex, that treats explicitly two rare and severe forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. Epidiolex’s approval is a landmark event for the Cannabis industry, as Epidolex is the first CBD derived drug to receive FDA approval for medical treatment of a condition.
CBD is the non-psychoactive component of the Cannabis plant because it contains negligible amounts of tetrahydrocannabinol (THC). In fact, to be classified as a CBD product in many jurisdictions, a product can contain no more than 0.03% THC.
Epidiolex’s approval is pivotal for the growing industry. Due to Cannabis currently being designated as a Schedule I controlled substance, it is tremendously difficult for researchers to conduct studies on medical applications or even obtain plants for future use in clinical trials. FDA Commissioner Dr. Scott Gottlieb notes that the FDA is open to research and drug development for Cannabis and CBD related drugs, so long as the clinical trials demonstrate safety and efficacy of a drug and that companies follow the complicated drug approval process.
Commissioner Gottlieb further expands that the FDA welcomes medical uses of Cannabis and CBD if these drugs are consistent and high quality – which are core tenants of Good Manufacturing Practices (GMPs). GMPs are the compliance standards set by the FDA that manufacturers must abide by in regulated industries, such as pharmaceuticals and dietary supplements.
While each state currently regulates Cannabis, it is a question of “when” this industry will be regulated by the FDA as opposed to “if.” There are several different routes that companies can explore, such as focusing specifically on pharmaceuticals or moving into the vaping industry. Time will tell the options available for all industry players and the regulations passed down.
Proactively complying with GMPs is not only a way for companies to stay ahead of the curve, but is an all-around positive investment. InstantGMP™ MES is a popular software solution for not only GMP compliance but helps companies elevate their brands. Learn more about how InstantGMP™ MES can help your brand gain a competitive edge.