Clinical trial data — wherever collected — must be reliable, inspectable, and ethically derived. If FDA can't inspect a site, that's a material factor in your regulatory strategy, not a footnote. Good clinical practice protects patients. The FDA will enforce it.
published
Clinical trial data — wherever collected — must be reliable, inspectable, and ethically derived. If FDA can't inspect a site, that's a material factor in your regulatory strategy, not a footnote. Good clinical practice protects patients. The FDA will enforce i
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