Writing the “Indications and Usage” Section of Labeling: FDA’s New Draft Guidance – Sep. 27, 2018

Iris P. Masucci from CDER’s Office of Medical Policy discusses FDA-approved labeling. She reviews how to write, organize, and format the information in the “Indications and Usage” section. She also covers general principles to consider when drafting the “Indications and Usage” section and when to include limitations of use in the “Indications and Usage” section. These considerations are based on the draft guidance “Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products – Content and Format.”
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