Safety
Referencing FDA's MedWatch Program
The following represents current information on reporting mechanisms that should be used when referring to FDA's MedWatch Program.
Adverse events, product quality problems, product use errors, or reports of therapeutic inequivalence/failure can be reported to FDA's MedWatch Safety Information and Adverse Event Reporting Program:
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- Online: www.fda.gov/MedWatch/report.htm
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178
- Phone: 1-800-332-1088
Examples of how such information could be incorporated in Dear Healthcare Professional letters:
| Healthcare professionals are strongly encouraged to submit a report of any serious adverse events that occur with the use of 'Product X' to 1-800-xxx-xxxx or to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm ], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178]. |
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Adverse events with "Product X' can be reported to 'XXXX' Pharmaceuticals by phone (888) xxx-xxxx or the Internet at www.xxxx.com . Alternatively, this information may be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088 [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page], by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178]. |