Minor OTC Monograph, Labeling Changes Face Major Hurdles, Firms Tell FDA
This article was originally published in The Tan Sheet
In comments on updating the OTC monograph system, P&G says “product innovations may be incremental and the existing [pathways] are not optimal approaches for manufacturers to request approval of minor changes,” and GSK urges FDA to develop mechanisms “to encourage innovation … by allowing the introduction of certain types of changes to products containing ingredients known to be safe and effective.”
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