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Article: FDA guidance on foreign clinical studies
- Article from:
- The Journal of Nuclear Medicine
- Article date:
- May 1, 2001
- Author:
CopyrightCopyright Society of Nuclear Medicine May 2001. Provided by ProQuest LLC. (Hide copyright information)
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Newsbriefs
NEWSLINE
On March 15, the U.S. Food and Drug Administration (FDA) released a brief guideline statement outlining conditions under which data from clinical studies performed outside the United States can be used to support applications for marketing approval. Guidance for Industry Acceptance ofForeign Clinical Studies (www fda.gov/cder/guidance/ index.htm) clarifies existing FDA requirements. In October 2000, the World Medical Association revised similar requirements that form part of the Declaration of Helsinki. The FDA noted that its own document was intended "to clarify that the action of the World Medical Association did not change FDA regulations."
The document reaffirmed ...