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39 FDA will also almost certainly continue to monitor websites, online labeling, and marketing materials, as we saw this year, and issue warning letters citing unapproved drug charges (for both COVID- and non-COVID-related products)

That step prevents one of the most common bench errors: switching to a fresh vial and forgetting that it was reconstituted to a different final volume than the last one

An FDA filing is now planned for Q1 2027

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