Current Edition

Guidance on Submissions for Integrated Summary of Effectiveness

For more than 30 years, the US Food and Drug Administration
(FDA) has required sponsors of new drug applications (NDAs)
to include in their submission an integrated summary of
effectiveness (ISE). The associated regulation, however, has
only provided brief details of the ISE’s necessary components.
To address that shortcoming, the FDA issued a final guidance
for industry in October 2015. Deborah A. Komlos, MS, Senior
Medical & Regulatory Writer for the Cortellis Regulatory
Intelligence US Module at Thomson Reuters, guides us on
submissions for integrated summaries of effectiveness.