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GUIDANCE DOCUMENT

Container Closure Systems for Packaging Human Drugs and Biologics -- Questions and Answers Guidance for Industry May 2002

Final

Container Closure Systems for Packaging Human Drugs and Biologics -- Questions and Answers

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This document provides questions and answers relating to the guidance on Container Closure Systems for Packaging Human Drugs and Biologics (the guidance). The questions are based on those posed to CDER by applicants.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.