U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Container Closure Systems for Packaging Human Drugs and Biologics -- Questions and Answers
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

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

Download the Final Guidance Document
Final
Docket Number:
None found
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug 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 Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: None found.

Back to Top