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International Pharmaceutical Regulatory Monitor
September 2008 | Vol. 36 No. 9
Guidance Outlines Effectiveness Summary for NDAs and BLAs
The integrated summary of effectiveness (ISE) required in new drug applications (NDAs) and encouraged in biologic licensing applications (BLAs) should include a detailed analysis of study results rather than just a summary of individual trials, according to a U.S. Food and Drug Administration (FDA) draft guidance.
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