MAPS: Medical Marijuana Research - Orphan Drug Designation for Smoked Marijuana in the Treatment of HIV-Associated Wasting Syndrome

The following letters (the letters of rejection and the amendments to the application in response to rejections) refer to MAPS' application to the FDA office of Orphan Product Development, "Request for Orphan Drug Designation for Smoked Marijuana in the Treatment of HIV-Associated Wasting Syndrome (application #97-1053).

May 1999: Letter of Approval from FDA for MAPS' ODD application
February 1999: MAPS' fifth amendment in response to the December 1998 rejection
December 1998: Third letter from FDA rejecting the application/amendments 2-4
November 1998: Fourth amendment from MAPS to the FDA
August 1998: Third amendment from MAPS to the FDA
June 1998: MAPS' 2nd amendment in in reponse to the 2nd FDA rejection
March 1998: Supporting letter from Dr. Alice Tang
November 1997: Second letter from FDA rejecting the application
October 1997: Supporting letter from Dr. Alice Tang
September 1997: MAPS' first amendment in reponse to the first rejection
September 1997: Supporting letter from Dr. Kathleen Mulligan
September 1997: Supporting letter from Dr. Donald Abrams
June 1997: First letter from FDA rejecting the application
April 1997: Letter from FDA acknowledging the application was received
April 1997: MAPS' original application to FDA

SUMMARY: Published in MAPS Bulletin Volume IX Number 3
MAPS Succeeds in Securing an Orphan Drug Designation for Marijuana (1999)