Track-and-Trace Deal Chances Trending Up
This article was originally published in The Pink Sheet Daily
GPhA head says Congress remains committed to passing its preferred lot-level tracking proposal and leadership in both congressional chambers will find a vehicle, possibly to get it passed during the upcoming lame-duck session.
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FDA has a tight deadline to finalize guidance on transaction information.
Industry groups will continue to search for legislative vehicles to move a national standard that would preempt state laws; near-term, though, manufacturers and distributors must prepare for California pedigree law.
CDER Director Janet Woodcock says an industry coalition’s proposal would not meet FDA’s drug tracking needs and is not worth the cost of implementing, even though industry says FDA’s preference is cost-prohibitive.