 |
Placement of Integrated
Summaries of Safety and Effectiveness (ISS/ISE) in Applications
Submitted in the eCTD Format
The CTD summary sections in Module 2 are not the correct
location for the integrated summaries of safety and effectiveness (ISS/ISE)
required by 21 CFR 314.50 (see
ICH M4: The CTD
-- Efficacy Q&As, and presentations from the
2006 Drug Information Association Meeting).
CTD submissions are being submitted electronically, it is important
that the location of ISS/ISE information in an eCTD be consistent:
- In an eCTD, the ISE and ISS go in Module 5,
section 5.3.5.3.
- If the narrative portions of the ISE and ISS are
suitable for use in Module 2, sections 2.7.3 and 2.7.4 of the CTD,
the documents are placed once in these sections and referenced in
Module 5, section 5.3.5.3 (i.e., provide leaf elements in section
5.3.5.3).
The following table lists the various sections of the CTD that
contain summary and integrated discussions of efficacy and safety and
the corresponding FDA regulations, where applicable, that inform the
content of those sections. Any questions about these matters can be
raised with the appropriate reviewing division at FDA.
|
CTD Section |
U.S. Regulation |
Comment |
| 2.5 Clinical Overview
(~30 pages) |
|
|
2.5.4
Overview of Efficacy
2.5.5 Overview of Safety |
n/a |
Not a U.S.
requirement, but recommended by ICH guidance |
| |
|
|
| 2.7 Clinical Summary
(~50-400 pages) |
|
|
2.7.3
Summary of Clinical Efficacy
2.7.4 Summary of Clinical Safety |
21 CFR 314.50
(c)(2)(viii) |
U.S. requirement for a
Clinical Summary |
| |
|
|
| 5.3 Clinical Study
Reports |
|
|
|
5.3.5.3 Reports of Analyses of Data from More than One Study
(Including Any Formal Integrated Analyses, Meta-Analyses, and
Bridging Analyses) |
21 CFR 314.50
(d)(5)(v)
21 CFR 314.50 (d)(5)(vi) |
Integrated Summary of
Efficacy Integrated Summary of Safety |
DIA Presentations
Gensinger, Gary, MBA, Director, Regulatory Review
Support Staff, Office of Business Process Support; Standards and
Successful Document Creation [PPT]
[PD]
Molzon, Justina, MS, Pharm, JD, Associate
Director for International Programs, FDA Center for Drug Evaluation
and Research; ISS/ISE: Where Do They Fit in the CTD/eCTD? [PPT]
[PD]
Oliva, Armando, MD, Associate Director for
Policy, FDA Office of New Drugs; ISE/ISS Analyses: Clarity in a
CTD or eCTD – Clinical Reviewer Perspective [PPT]
[PD]
Temple, Robert, MD, Associate Director for
Medical Policy, FDA Center for Drug Evaluation and Research; CTD
– ISS/ISE Introduction and Summary of Issues [PPT]
[PD]
Back to Top
Electronic Common Technical Document
PDF requires the free
Adobe Acrobat Reader
Date created: September 12, 2006 |
|
