Home » U.S. FDA Issues Common Technical Document Guidance
U.S. FDA Issues Common Technical Document Guidance
August 15, 2007
According to new FDA draft guidance on common technical documents (CTD), a format for submitting new drug and biologics license applications, manufacturers are advised that submissions of integrated summaries of effectiveness (ISE) and integrated summaries of safety (ISS) are not to be included in the clinical summary sections of CTDs.
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