No. The FDA believes that scientifically valid research conducted under an IND application is the best way to determine what patients could benefit from the use of drugs derived from marijuana. The FDA supports the conduct of that research by:
Providing information on the process needed to conduct clinical research using marijuana.
Providing information on the specific requirements needed to develop a drug that is derived from a plant such as marijuana. In June 2004, the FDA finalized its Guidance for Industry: Botanical Drug Products, which provides sponsors with guidance on submitting IND applications for botanical drug products.
Providing specific support for investigators interested in conducting clinical research using marijuana and its constituents as a part of the IND process through meetings and regular interactions throughout the drug development process.
Providing general support to investigators to help them understand and follow the procedures to conduct clinical research through the FDA Center for Drug Evaluation and Research’s Small Business and Industry Assistance group.
