ARTICLES BY NATALIE ABTS
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Examining FDA’s New Patient Labeling Draft Guidance9/9/2019
The FDA recently released the draft guidance document Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products – Content and Format. Instructions for use (IFU) are a critical element of the device user interface, and special considerations must be accounted for in their design.
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