The Integrated Summary of Safety (ISS) submitted with a New Drug Application is used by sponsors and regulators to evalutate a new drug's safety profile. Preparing an ISS is a labor and intellectually intensive process requiring input from many areas of expertise within the pharmaceutical company including medical writing, regulatory affairs, clinical research, biometrics, data management, and programming. This article describes the approach to document production used at Parke-Davis Pharmaceutical Research Division of Warner Lambert Company and some guidelines for preparing an ISS from a writer's perspective.
Food and Drug Administration.Code of Federal Regulations (CFR). 21:314.50(d)(5), 1989.
2.
TempleRJThe regulatory evolution of the integrated Safety Summary. Drug. Inf J.1991;25:485–492.
3.
LineberryC.Approaches to describing common adverse events in the Integrated Safety Summary. Drug Inf J.1991;25:493–500.
4.
ScholtesPRThe Team Handbook How to Use Teams to Improve Quality.Madison, WI: Joiner Associates Inc.; 1990.
5.
HaynesMEEffective Meeting Skills A Practical Guide for More Productive Meetings.Menlo Park, CA: Crisp Publications, Inc.; 1988.
6.
KnutsonJBitzI.Project Management: How to Plan and Manage Successful Projects.New York: AMA-COM; 1991.
7.
MathesJCStevensonDWDesigning Technical Reports: Writing for Audiences in Organizations. (2nd Edition). New York, NY: Macmillan Publishing Co; 1991:295.
8.
IversonC. (ed.). American Medical Association Manual of Style. (8th Edition); Baltimore, MD: Williams and Wilkins; 1989.
9.
The Chicago Manual of Style. (13th Edition, Revised and Expanded). Chicago, IL: University of Chicago Press; 1982.
10.
ZeiglerM.Essentials of Writing Biomedical Research Papers.New York, NY: McGraw-Hill, Inc.; 1991.
