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Re: None

Tuesday, 09/01/2009 4:09:13 PM

Tuesday, September 01, 2009 4:09:13 PM

Post# of 6487
FDA amendment published april 2008 relax the requirement to file an IND based on foreign clinical studies which were once based on the ethical principles stated in the 1989 version of the Declaration of Helsinki or the laws and regulations of the country in which the research was conducted, whichever provided for the greater protecrtion for the individual. With the new rule based on GCP [Good Clinical Practice], in addition to the influence the board has, there should be no problem getting the process going based on foreign clinical studies