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GUIDANCE DOCUMENT

Draft Points to Consider in the Design and Implementation of Field Trials for Blood Grouping Reagents and Anti-Human Globulin January 1992

Final
Docket Number:
91N-0467
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

In response to concerns expressed over the intent in performing field trials on new Blood Grouping Reagents and Anti-Human Globulin Reagents and the subsequent impact on field trial design and implementation, a portion of the November 1990 workshop, "Reagents for the 1990's" was devoted to the discussion of these parameters. A consensus was reached on many elements and the major points of concern have been incorporated into this document. It should be noted that these products have not required the filing of an Investigational New Drug Application (IND) for conducting field trials.


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: 91N-0467.

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