Form for reporting serious adverse events and product problems with human drug and biological products and devices; availability--FDA. Notice.
The Food and Drug Administration (FDA) is announcing the availability of a new form for reporting adverse events and product problems with human drug products, biologic products, medical devices (including in-vitro diagnostics), special nutritional products (dietary supplements, medical foods, infant formulas), and other products regulated by FDA. There are two versions of the form. One version of the form (FDA Form 3500) is available for use by health professionals for voluntary reporting; the other version of the form (FDA Form 3500A) is to be used by user facilities, distributors, and manufacturers for reporting that is required by statute or FDA regulations. The new form will simplify and consolidate the reporting of adverse events and product problems and will enhance agency-wide consistency in the collection of postmarketing data. This notice also responds to written comments the agency received on proposed versions of this form. Copies of both versions of the new form appear at the end of this document.
D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards*; D001688:Biological Products / Q000009:adverse effects; D064420:Drug-Related Side Effects and Adverse Reactions; D004864:Equipment and Supplies / Q000009:adverse effects; D005568:Forms and Records Control; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration