Writing the “Indications and Usage” Section of Labeling: FDA’s New Draft Guidance – Sep. 27, 2018
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YouTubeU.S. Food and Drug Administration
Writing the “Indications and Usage” Section of Labeling: FDA’s New Draft Guidance – Sep. 27, 2018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 ...
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Food and Drug Administration FDA Approvals
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