Drugs

Combination Products

Draft and Final guidances can also be found on the Office of Combination Products web site.

Below is a sortable listing of Combination Products Guidances 

CategoryTitleTypeDate
Combination Products Coronary Drug-Eluting Stents— Nonclinical and Clinical Studies (PDF - 502KB) Draft 03/26/08
Guidance for Industry Coronary Drug-Eluting Stents— Nonclinical and Clinical Studies Companion Document (PDF - 212KB) Draft Guidance 03/27/08
Draft Guidance for Industry and FDA Staff - Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4 Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4 - Draft Guidance for Industry and FDA Staff (Printer-friendly) (PDF - 98KB) 04/01/13

Page Last Updated: 07/10/2015
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