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19
Reporting adverse events to FDA
MedWatch is the Food and Drug Administration’s (FDA) program for reporting serious reactions,
product quality problems, therapeutic inequivalence/failure, and product use errors with human
medical products, including drugs, biologic products, medical devices, dietary supplements, infant
formula, and cosmetics.
If you think you or someone in your family has experienced a serious reaction to a medical product,
you are encouraged to take the reporting form to your doctor. Your health care provider can
provide clinical information based on your medical record that can help the FDA evaluate your
report. However, we understand that for a variety of reasons, you may not wish to have the form
lled out by your healthcare provider, or your health care provider may choose not to complete
the form. Your health care provider is not required to report to the FDA. In these situations, you
may complete the Online Reporting Form yourself.
You will receive an acknowledgement from the FDA when your report is received. Reports are
reviewed by FDA sta. You will be personally contacted only if we need additional information.
Submitting adverse event reports to FDA
Use one of the methods below to submit voluntary adverse event reports to the FDA:
1. Report Online at: www.accessdata.fda.gov/scripts/medwatch/index.
cfm?action=reporting.home
2. Consumer Reporting Form FDA 3500B. Follow the instructions on the form to either
fax or mail it in for submission. For help lling out the form, see MedWatchLearn. The
form is available at: www.fda.gov/downloads/aboutFDA/reportsmanualsforms/forms/
ucm349464.pdf
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