After month of deliberation, the al...
After month of deliberation, the aliment and Drug Administration issued a final regulation 31 May 2002 that permits pharmaceutical and biotech companies to search for approval of certain vaccines and medicines based forward efficacy testing only in animals. The policy requires routine safety testing in humans while relying upon use of animal models to determine efficacy in preventing or treating individuals expos to toxic substances that cannot ethically be ordealed in human volunteers. FDA is finalizing a propos control issued in 1999 that has been forward hold pending resolution of several tonic ...
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