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Ann: FDA Approves SOFDRA as Trade Name for Sofpironium Bromide, page-74

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    I'm not sure what previous post your are referring to, but the actual labelling guide from the FDA (Instructions for Use —Patient Labeling for Human Prescription Drug and Biological Products — Content and FormatGuidance for Industry - July 2022) does NOT stipulate instructions must be in portrait format.

    In fact, Note 7 on page 2 is clear - 7 The format recommendations presented in this guidance are written to apply to an IFU document presented in portrait orientation on letter size paper (8.5 x 11). We recommend that IFU documents presented in other formats aim to carry over as many format recommendations as practical unless information or data, such as data from HF studies, would support otherwise.
 
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