U.S. FDA Wary About “Paying The Price” For Mistakes Based On Foreign Data
This article was originally published in PharmAsia News
It is going to take time for the public and policymakers to get comfortable with the idea of U.S. FDA making regulatory decisions based on information from other countries, Commissioner Hamburg says.
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FDA commissioner believes the agency needs to have “a full place at the table,” rather than being summoned into the process late and viewed as obstructionist when it raises public health concerns.
As Congressional markups of user fee bills looms, the agency describes actions it has taken to protect the international supply chain in its Global Engagement report; another report notes the REMS and drug safety studies it has mandated under its postmarket drug safety program.
The agency still plans to move forward with coalition-building and increased data-sharing aspects of globalization initiative.