ABSTRACT

Guidance for Industry: How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1)   [open pdf - 51KB]

"This guidance for industry has been developed to clarify what information should be obtained before an individual case of an adverse experience after immunization should be submitted to the Vaccine Adverse Event Reporting System (VAERS). The Food and Drug Administration (FDA) believes that the recommendations in this guidance document will improve the quality of postmarketing safety reports and clarify the industry's current safety reporting responsibility to assure public health."

Publisher:
Date:
1998-09
Copyright:
Public Domain
Retrieved From:
Military Vaccines Website: http://www.vaccines.army.mil/
Format:
pdf
Media Type:
application/pdf
URL:
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