Track And Trace System Could Start With RxTEC As Foundation, FDA Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Compromise proposal from agency would allow lot-level tracking at first, if there was a “clear path” to a more advanced system in subsequent years.
You may also be interested in...
Gray Market Investigation Could Push Track-and-Trace Debate
Rep. Cummings and Sen. Rockefeller suggest serialization is not an adequate replacement for state pedigree laws in letter to House and Senate leaders conferencing on user fee bills.
PDUFA’s ‘Huge’ GMP Change Will Tie Adulteration To Quality System
Legislative language would consider a drug adulterated if it does not have the necessary quality management systems in place as required in current Good Manufacturing Practices.
GMP Carrots For Quality: FDA Considers Incentives To Adopt Quality Systems
The type of incentive remains under consideration, but one suggestion is a grading system similar to what restaurants receive from local health departments.