A comprehensive clinical plan developed by MAPS in consultation with the FDA for the investigation of marijuana’s medical use in the treatment of the HIV-related wasting syndrome. This Clinical Plan was submitted with Dr. Donald Abrams’ research protocol (IND#43,542) comparing the effectiveness of smoked marijuana and the oral THC capsule in promoting weight gain in patients suffering from the AIDS wasting syndrome.It is designed to also be adapted for indications other than the wasting syndrome. Originally printed in the Summer 1994 MAPS Newsletter.
Minimum Informational Requirements for Establishing an FDA Drug Master File for Cannabis – Questions To Be Answered by Potential Manufacturers.