Peter Lurie Quotations
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Compliant Quotes
Before, you couldn't get back and forth to these countries the way you can now. You couldn't share data electronically the way you can now. Even if people had the temptation to go overseas before because of less regulation, more compliant populations or study designs that they couldn't pull off locally, logistically it was not possible until recently. That's where globalization comes in.
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Ability Quotes
The underlying problems is that the FDA has little ability to enforce these commitments, short of withdrawing approval for the drug - an outcome that may not serve the public health well. The great majority of post-marketing studies address safety issues, at least in part, so patients and physicians are denied critical safety information when these studies are not completed in a timely fashion.
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Ability Quotes
The underlying problem is that the FDA has little ability to enforce these commitments, short of withdrawing approval for the drug - an outcome that may not serve the public health well. The great majority of post-marketing studies address safety issues, at least in part, so patients and physicians are denied critical safety information when these studies are not completed in a timely fashion.