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study results rather than just a summary of individual trials, according to a U.S. Food and Drug Administration (FDA) draft guidance.
300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.
Phone (703) 538-7600 - Fax (703) 538-7676 - Toll free (888) 838-5578.
Copyright by FDAnews. All rights reserved. Do not duplicate or redistribute in any form.