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GUIDANCE DOCUMENT

Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency Guidance for Industry June 2008

Final
Docket Number:
2005D-0438
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

We, FDA, are providing you, Investigational New Drug Application (IND) sponsors and Biologics License Application (BLA) applicants, recommendations for testing the safety and efficacy of Immune Globulin Intravenous (Human) (IGIV) products as replacement therapy in primary humoral immunodeficiency. The document provides guidance on general principles concerning clinical trial design to evaluate safety, efficacy, and pharmacokinetics of investigational IGIV products and is intended to assist you in the preparation of the clinical/biostatistical and human pharmacokinetic sections of a BLA. This guidance does not address evidence of clinical efficacy for other indications, or other sections of a BLA such as chemistry, manufacturing, and controls and preclinical toxicology.


Submit Comments

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: 2005D-0438.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
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Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010