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OTC Monograph Bill Has Energy And Commerce Date, CDER Director's Hope

This article was originally published in The Pink Sheet & The Rose Sheet

Executive Summary

US House is catching up with Senate on OTC monograph legislation, with a committee markup expected in the next few days.

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The length of exclusivity periods is the only major difference between pending US House and Senate bills, both largely based on a proposal developed by FDA and drug industry representatives. Committees in both chambers are expected to vote on moving the bipartisan proposals to floor votes within two months.

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