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US FDA Raises Problems With EU Data Protection Reg, But Are They Among Those Misunderstanding It?

 
• By Derrick Gingery

An FDA blog post says some inspections have been hindered and application assessments soon could be delayed by the EU General Data Protection Regulation (GDPR), but experts argue the law includes directions to allow data sharing and remain compliant.

data protection
An FDA official said its application assessments could be affected by the GDPR. • Source: Shutterstock

The European Union’s General Data Protection Regulation (GDPR) already has hindered clinical research site inspections and the US Food and Drug Administration is worried the law soon could create problems for application reviews.

But a data privacy expert said the real problem may be that the FDA, like many other stakeholders, does not fully understand the law and the potential benefits of the...

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