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Guideline for Adverse Experience Reporting for Licensed Biological Products


VI. How to report.

A form FDA 3500A is used to report adverse experiences associated with licensed biological products other than vaccines. Adverse experiences associated with licensed vaccine' are to be reported using the VAERS form.

An abbreviated form FDA 3500A, which replaces section D with section G, may be used when reporting only drugs or biological products.

Computerized Forms.
In place of using the preprinted forms, a computer-generated report may be submitted if:

Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20852-9787

To request approval of a VAERS-1 form, submit a printed copy with data to illustrate how each data field will be reported to:

Division of Biostatistics and Epidemiology (HFM-210)
Center for Biologics Evaluation and Research, FDA
1401 Rockville Pike
Rockville, MD 20852-1448

A computerized graphic of the FDA 3500A form is available from the Division of Biostatistics and Epidemiology.

Electronic Submissions.
Electronically produced adverse experience reports may be submitted; however, each licensed manufacturer must obtain prior written approval.

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