Track And Trace Could Go Off The Rails Due To Dispenser Exemption
Several groups have problems with a proposed exemption for pharmacists from compliance with potential unit-level tracking standards in the latest track-and-trace proposal.
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Sen. Burr Tries To Pull FDASIA Over For Speeding As Senate Sends Bill To White House
The North Carolina Republican spends more than two hours talking about the user fee bill and other issues in an apparent effort to delay a final vote, but the Senate easily passes it.
Track-and-Trace Deal’s Failure Leaves California In Control Of Agenda
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.
Track And Trace: Substandard System Is Not Better Than Nothing, FDA Says
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.