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Reporting Adverse Events and Product Deviations

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Biological Product Deviation Reporting

Reporting system for errors and accidents in manufacturing of products, including testing, processing, packing, labeling, or storage, or with the holding or distribution of a licensed biological product or a blood or a blood component, in which the safety, purity, or potency of a distributed product may be affected.

 

Notification Process for Transfusion Related Fatalities and Donation Related Deaths

Instructions for notifying CBER about deaths related to blood transfusions or blood donations.

 

Vaccine Adverse Event Reporting System (VAERS)

Created by the Food and Drug Adminstration and the Centers for Disease Control, this system is used to report adverse events or side effects related to the administration of a vaccine.

 

FDA MedWatch - The FDA Medical Products Reporting Program

The purpose of the MedWatch program is to enhance the effectiveness of postmarketing surveillance of medical products as they are used in clinical practice and to rapidly identify significant health hazards associated with these products.

Updated June 25, 2002
 
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