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A Pre-Sub is a formal written request for feedback from FDA prior to your pre-market submission that you can use to request information on a variety of topics related to your submission

Any unused portion can be stored for later use for up to 60 days after initial opening instead of being discarded at the days end, as is the case with other injections

A completed ICE submission typically results in an adjustment to amounts billed in the previous year (either under-billed or over-billed)

So the question isn't always whether B12 treatment caused an iron issue - it may be whether one was already there, just less obvious