US FDA Cannabis Product Development Guidance for Industry
Time & Location
About the event
An 20-min overview of the FDA Cannabis Derived Product Development Guidance for Industry, followed by 30 mins Q&A:
- Since the Congress passed legislation to legalize hemp products, there is a boom for the cannabis industry. Currently, all hemp products are marketed as dietary supplements.
- Competitive market forces sponsors to differentiate their products through clinical research, and sometimes clinical trials.
- Products in the dietary supplement category are not allowed to advertise medical benefit of treating or preventing diseases. From FDA's perspective, if sponsors believe their hemp products are capable to treat or prevent diseases, sponsors should develop their products through the IND process.
- The FDA botanical drug development pathway allows IND drug products to be plant extracts, whole plant, or plant mixture; waives requirement of identifying active ingredients or mechanism of action. As long as the IND products demonstrate safety and efficacy in phase 1,2 3, trials, they are approved as prescription drugs
- The definition for hemp is "dry weight of THC < 0.3%".
$50/person, 10 seats/event limit to make sure that each participatent can ask his questions. Those registerred from the No 11, will be on the waiting list.
A payment link will send to registrants 3 weeks before the event, a payment is required to confirm a seat.