Track-And-Trace Will Not Hitch A Ride On The User Fee Train
This article was originally published in The Pink Sheet Daily
Efforts to reach a consensus proposal have been unsuccessful as the bill nears a possible final vote in the House.
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Track-and-trace measure goes to floor coupled to compounding bill, but the all-smiles markup in the Senate HELP Committee is more than made up for by the differences that remain with the House version.
The difference in approach to unit-level tracing underscores the difficulty supporters of a national track-and-trace program face in gaining final approval of a bill before manufacturers go too far down the road in implementing a California pedigree law that goes into effect in 2015.
FDA’s Center for Drug Evaluation and Research plans to publish more than 50 new and revised draft guidances this calendar year.