FDA Wary About “Paying The Price” For Mistakes Based On Foreign Data
It is going to take time for the public and policymakers to get comfortable with the idea of FDA making regulatory decisions based on information from other countries, Commissioner Hamburg says.
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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.
Institute of Medicine report recommends how FDA, industry and other stakeholders can strengthen food and drug regulatory systems abroad. It calls for FDA to provide incentives for foreign regulators to meet U.S. standards and facilitate training and for the government to help hold importers liable.
The agency still plans to move forward with coalition-building and increased data-sharing aspects of globalization initiative.