Posted By
Teresa Skarr
15-May-2020 12:07
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RAPS Twin Cities Chapter
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Hi Sourav, This sounds very similar to a project I worked on back in 2004, with the only change being from Rx to over-the-counter. Although it's technically not an indication change since you already have clearance for home use, FDA does handle this as a labeling change that wouldn't be eligible for ...
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