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2. FDA Adverse Event Reporting System (FAERS)

   www.fda.gov/drugs/drug-approvals-and-databases/fda-adverse-event-reporting...

   FDA Adverse Event Reporting System supports the FDA's post-marketing safety surveillance program for all marketed drug and therapeutic biologic products.

3. FDA Adverse Event Reporting System (FAERS) Public Dashboard

   www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system...

   FDA Adverse Event Reporting System (FAERS) Public Dashboard. The FAERS Public Dashboard is a highly interactive web-based tool that will allow for the querying of FAERS data in a user...

4. What is a Serious Adverse Event? - FDA

   www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event

   An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the patient outcome is: Death....

5. CFR - Code of Federal Regulations Title 21 - Food and Drug...

   www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.32

   Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Life-threatening adverse event or...

6. FDA Adverse Event Reporting System

   open.fda.gov/data/faers

   The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database is designed to...

7. FDA Adverse Event Reporting System - Wikipedia

   en.wikipedia.org/wiki/FDA_Adverse_Event_Reporting_System

   The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products.

8. Adverse Event Detection, Processing, and Reporting

   www.ncbi.nlm.nih.gov/books/NBK562574

   The FDA maintains MedWatch, a Web-based reporting system that allows consumers and health professionals to voluntarily report serious adverse events and other serious problems that they suspect are associated with the use of an FDA-regulated product. 11

9. Drug Adverse Event Overview - Food and Drug Administration

   open.fda.gov/apis/drug/event

   The openFDA drug adverse event API returns data that has been collected from the FDA Adverse Event Reporting System (FAERS), a database that contains information on adverse event and medication...

10. 21 CFR Part 600 Subpart D -- Reporting of Adverse Experiences

    www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-600/subpart-D

    Any adverse experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.

11. VAERS - Report an Adverse Event

    vaers.hhs.gov/reportevent.html?os=win&ref=app

    The Vaccine Adverse Event Reporting System (VAERS) is a national early warning system to detect possible safety problems in vaccines used in the United States. VAERS accepts and analyzes reports of adverse events (AEs) after a person has received a vaccination. ... Serious adverse events per FDA are defined as: Death; A life-threatening adverse ...