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In summary, FDA policy mandates the use of immunosuppressive drugs inorgan transplantation clinical trials (in the control arms) that are no longerthe preferred regimen of drugs of transplant physicians. The letter can bereviewed by going to www.a-s-t.org .
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About AST
The American Society of Transplantation (AST) was founded in 1982 and isan organization of more than 2,700 transplant professionals dedicated toimproving patient care through the promotion of research, education, advocacyand organ donation. AST provides a forum for the exchange of knowledge,scientific information and expertise in the field of transplantation.
If you are interested in speaking with the letter's primary author, Dr.Vincenti, or would like to receive a copy of the letter, please contact BethDrost at 215.884.6499.Vincenti maintains that FDA policy has: -- discouraged many transplant centers from participating in clinical trials of new transplant drugs -- driven American patients away from enrolling in clinical trials -- caused drug companies to seek patients outside the U.S. for clinical trials -- weakened clinical trial results of innovative transplant drugs
SOURCE American Society of Transplantation
