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:

(a) it contains all the elements of information in the identical enumerated sequence of the form;
(b) is completed according to this Guideline.
The typeset should be clear enough to ensure readable digital copies. Each licensed manufacturer's use of a modified form must be pre-approved by FDA in writing. To request approval of an FDA 3500A form, submit a printed copy with data to illustrate how each data field will be reported to:

MedWatch
Food and Drug Administration
(HF-2)
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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