How to submit a case to the FDA

March 15, 2005

The best way to submit cases to the FDA is to use the form at www.fda.gov/medwatch/report.htm. Using this form requires an individual form be filled out for each case.

The best way to submit cases to the FDA is to use the form at http://www.fda.gov/medwatch/report.htm. Using this form requires an individual form be filled out for each case. If physicians are submitting multiple reports, they can download a fillable pdf version of the 3500 form at http://www.fda.gov/medwatch/safety/fda-3500_fillable.pdf. which allows them to fill out the form from a desktop computer, save copies of the pdf file, and print out the one-page form to fax to the FDA at 800/332-0178.

The MedWatch site that describes all options for submitting voluntary reports is http://www.fda.gov/medwatch/report/hcp.htm.

Physicians can also report cases directly to the manufacturer's drug information unit at 800/542-6257 (press option 4).