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Senate OTC Monograph Legislation Tracks House Bill On Exclusivity

 
• By Malcolm Spicer

Both bills allow 18-month market exclusivity periods for marketers of some products made available through additions or changes to OTC monograph, through which the majority of nonprescription drugs are made available in US. Senate bill in markup 31 October.

United States Capitol Building at sunset - Washington, DC, USA - Image

A difference that marked previous House and Senate bills that would modernize and overhaul the Food and Drug Administration's OTC monograph program is resolved as Sens. Bob Casey and Johnny Isakson introduce legislation mirroring a House bill introduced in June.

Casey, D-PA, and Isakson, R-GA, on 30 October introduced the Senate "Over-the-Counter Monograph Safety, Innovation, and Reform Act," S.2740,...

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