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I. Introduction
Reference Information:
- About this guidance document
- To obtain copies of this document
- For questions regarding this document
- FDA office that authored this guidance
March 2014
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How to comment on this document
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How to comment on this document
How to comment on this document
Submit one set of either electronic or written comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You should identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.
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[email protected], or from the Internet at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
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For questions regarding this document
For questions on the content of this guidance, contact OCOD at the phone numbers or email address listed above.
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FDA office that authored this guidance
U.S. Department of Health and Human Services
Food and Drug Administration
- Center for Biologics Evaluation and Research
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