FDA 3500. MedWatch Form
The FDA Form 3500, also known as the MedWatch Form, is used to report adverse events related to FDA-regulated products. The form consists of several parts, including the patient information section, the adverse event information section, and the product information section.
Important fields on the form include the patient's demographic information, the date the product was first used, the adverse event symptoms, and the product information such as the name, strength, and dosage form.