FDA Botanical Drug Development Pathway for Cannabis Products Containing Hemp

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

 

In Feb 2020, FDA issued an opinion to encourage cannabis companies to develop cannabis products to prescription drugs through botanical drug development guidance for industry. In general, the process is:

  • Sponsor obtains pre-IND number through CDER review division to request a pre-IND meeting. For new animal drug research, a sponsor may engage with CVM to establish an INAD file. A pre-IND meeting with CDER is optional, and an opportunity to obtain FDA guidance on sponsor research plans and required content for an IND submission.

 

  • Sponsor provides all applicable chemistry, manufacturing, and controls (CMC) and botanical raw material (BRM) information in the IND for review by FDA, including hemp cultivars.

 

  • If the selected hemp manufacturer holds a Drug Master File (DMF), the sponsor must obtain a Letter of Authorization (LOA) to reference CMC and BRM information. Alternatively, an IND submission would need to contain all necessary CMC data characterizing their study drug and ensuring it is safe for use in humans.

 

  • The sponsor sends a copy of the IND and clinical protocol, including a LOA (if applicable), to FDA.

 

  • FDA reviews the submitted IND. The sponsor must wait 30 calendar days following IND submission before initiating any clinical trials, unless FDA notifies the sponsor that the trials may proceed sooner. During this time, FDA has an opportunity to review the submission for safety to assure that research subjects will not be subjected to unreasonable risk.

Philadelphia, USA