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Daily Dashboard | Op-ed: EU GDPR creates research hurdles for US FDA Related reading: TikTok faces potential 27M GBP fine from ICO



The EU General Data Protection Regulation presents a handful of challenges to U.S. Food and Drug Administration research conducted in Europe. The FDA’s bioresearch monitoring program, which is responsible for the conduct and reporting of FDA-regulated research, has been most affected by the GDPR, attorney Heather Messick writes. She said other areas of FDA research impacted by the GDPR are access to clinical trial data, drug and biologic license applications, and adverse event reporting.
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