E-drug: Good or bad clinical practice? (2)
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The FDA is the first regulatory authority that routinely carry out
clinical trial audit, but right now the U.S. is not the only country
that implement this policy. Regulatory authorities in Japan and Sweden
also audit clinical trials. Shortly before the Department of Health in
Taiwan announced its own Good Clinical Practice guidelines, FDA officers
were invited to come to Taiwan to train clinical trial inspectors.
Selected clinical trials carried out in Taiwan for drug registration
purpose will be inspected.
K. Arnold Chan
Harvard School of Public Health
Email: kachan@epinet.harvard.edu [manually added; WB]
[Can E-druggers please add Email, Telephone, Fax and Snailmail addresses to
their signature files? The moderators can manually copy the email
addresses, but we would prefer them to be in a standard signature file.
Thanks! WB]
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