Federal register
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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. ⋯ 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.