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GUIDANCE DOCUMENT

Draft Recommended Methods for Evaluating Potency, Specificity, and Reactivity of Anti-Human Globulin March 1992

Final

Draft Recommended Methods for Evaluating Potency, Specificity, and Reactivity of Anti-Human Globulin

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

In follow-up to the 7-9 November 1990 workshop "REAGENTS FOR THE1990's", the comments received from licensed manufacturers of Blood Grouping Reagents, users, and other interested parties concerning "Proposed Revised erformance Criteria for Anti-Human Globulin Reagents" were reviewed and incorporated into this document. A summary of the changes that have been made is included on page (ii).


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.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010