American Botanical Drug Association

1. FDA Guidance on Hemp Product Development

• In September of 2018, the FDA approved Epidiolex (Cannabidiol) Primer, the first plant-derived, purified pharmaceutical-grade cannabidiol (CBD) medication to treat Dravet syndrome or Lennox-Gastaut syndrome.​

​​

• In February of 2020, FDA issued an opinion to encourage cannabis companies' development of cannabis products into prescription drugs through botanical drug development guidance for industry.

​​

• In July of 2020, the FDA developed a draft GFI "Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry."​​