Law360, New York (September 06, 2013, 5:06 PM ET) -- The rest of 2013 could reshape the pharmaceutical industry as regulators potentially issue guidance on biosimilars and Congress weighs bills related to drug tracking and compounding pharmacies .
On the legislative side, rare bipartisan cooperation is driving pushes for a track-and-trace system and stronger oversight of compounders, and passage of reform measures seems probable. The likelihood of new regulation emerging from the U.S. Food and Drug Administration is harder to gauge, as regulators have been tight-lipped about their timetable for issuing long-awaited guidance on copycat biologics....
On the legislative side, rare bipartisan cooperation is driving pushes for a track-and-trace system and stronger oversight of compounders, and passage of reform measures seems probable. The likelihood of new regulation emerging from the U.S. Food and Drug Administration is harder to gauge, as regulators have been tight-lipped about their timetable for issuing long-awaited guidance on copycat biologics....
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