, 3 tweets, 1 min read Read on Twitter
@SarahKarlin Setting aside any particular matter specific to any one company, sometimes it’s the case that companies will try to file under pathways that aren’t open to them. Allergenic-type products only meet criteria to fall outside the allergenic category in very specific circumstances.
@SarahKarlin When confusion does occur by sponsors it’s highly unfortunate and we always try hard to provide clarification where appropriate. As a general matter, if all of a sponsor’s interactions are with the allergenic products division, it’s an indication that it’s an allergenic product.
@SarahKarlin These scientific and regulatory decisions and determinations are made independently, by career scientific and program experts
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