Potential Governing Body Emerges For DSCSA Tracing Of US-Marketed Drug Packages
The idea of establishing a non-profit governance group to coordinate the package-level tracing of pharmaceuticals through the US distribution chain that DSCSA requires drew widespread support at a May 1 PDSA meeting in Washington, DC. PDSA wants to get the group up and running by October.
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New DSCSA Track And Trace Governing Body Up And Running
Despite some previous uncertainty about sufficient funding commitments from members, the coalition of manufacturers, wholesalers and distributors is operational, with a meeting planned for early next year. It will oversee data governance systems for implementing the US supply chain safety law, a key element of the law's third phase set to go into effect November 2023.
PDSA Asks Stakeholders To Join DSCSA Track-And-Trace Governing Body By September
But there’s a wrinkle: Many prospective participants cannot budget for the tiered fees until 2020.
Program Participants Urge The FDA To Adopt Some Pharmaceutical Quality Metrics And Avoid Others
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”