Home › Blogs › Leah_Kleylein's blog ›

FDA creates Guidance on ISS/ISE Placement

Submitted by Leah_Kleylein on Tue, 04/21/2009 - 14:34.
in
This morning I saw that FDA put out an actual guidance on placement of the ISS/ISE.

Before they had the webpage (and still reference it in the guidance): http://www.fda.gov/cder/regulatory/ersr/ISS_ISE_clarification.htm

The guidance can be found at:  http://www.fda.gov/cder/guidance/8524fnl.pdf

They've reproduced the same table from the webpage in the guidance (as Table 1) and then just spent time talking about it all.

They also describe the exception case:

C. Exceptions

There may be situations in which sections 2.7.3, Summary of Clinical Efficacy, and 2.7.4, Summary of Clinical Safety, would be sufficiently detailed to serve as the narrative portion of the ISE and ISS, respectively, while still concise enough to meet the suggested size limitations for Module 2. This situation is rare but can occur if the application is small and consists of a single study or a number of small studies. In our experience, the narrative portion of the ISE often is more amenable for inclusion in Module 2 than is the ISS. In such situations, the ISE and ISS can be split across Module 2 and Module 5, with the narrative portion located in section 2.7.3 or 2.7.4 and the appendices of tables, figures, and datasets located in section 5.3.5.3. If the ISE or ISS is split across modules in this way, it is critical to include a clear explanation of where the parts are located. This explanation should be placed both in Module 2 (section 2.7.3 or 2.7.4) and in Module 5 (section 5.3.5.3).


Finally, they give some examples of real life cases that have been taken from various FDA presentations to the industry.

Nothing major, but good to know this now exists.