MedWatch - Referencing FDA's MedWatch Program

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 and/or product use errors can be reported to FDA's MedWatch Adverse Event Reporting program:

online [at www.fda.gov/MedWatch/report.htm ]
by phone [1-800-FDA-1088]
by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm]
- by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787]
- by fax [1-800-FDA-0178]

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 Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm ], by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

-- or --

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 Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm], by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].