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Shorter Exclusivity In House OTC Monograph Bill Could Gain Industry Acceptance To Speed Passage

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

Executive Summary

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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