FDA Should Have Larger Role In Trade Talks, Hamburg Says
This article was originally published in The Pink Sheet Daily
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.
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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.
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 goal of the Office of New Drugs’ initiative is to develop and execute, in a cross-disciplinary manner, strategic plans to address substantive development hurdles in specific therapeutic areas. This approach already has been used for non-healing, chronic wounds and is being expanded to neurodegenerative and rare diseases, OND’s Peter Stein tells the Pink Sheet.