OTC Monograph Reform Momentum Carries Potential Exclusivity Snag
This article was originally published in The Pink Sheet & The Rose Sheet
Executive Summary
Support was unanimous during House Health Subcommittee markup for draft legislation on streamlining FDA's monograph system by eliminating public rulemakings from the process and allowing the agency to make decisions with administrative orders. Two-year exclusivity for some products didn't go over so well.
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