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    Preparing for virtual regulatory meetings

    This article discusses how sponsors can prepare for their meetings with regulators in light of the recent FDA and EMA announcements that Advisory Committee meetings and Oral Explanations—as well as other “essential” regulatory meetings—will be conducted virtually. While this article specifies Advisory Committee meetings and Oral Explanations, the need for preparedness and tools described also applies to any virtual meetings that are held with health authorities.   Intro...