US FDA Raises Problems With EU Data Protection Reg, But Are They Among Those Misunderstanding It?
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.
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Companies often do not focus on biomarker development and validation until too late in the game, FDA officials said at a recent Duke-Margolis meeting; experts cited the need for precompetitive work and public-private collaborations with an emphasis on early engagement, data sharing and transparency.
A senior regulator from the European Medicines Agency says that while the EU General Data Protection Regulation can be intellectually challenging, the law is needed, and it should not deter companies from conducting decentralized clinical trials because of concerns they might have over the use of digital tools to capture and process patient and trial data.