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Data Integrity New Regulations

ArentFox Schiff

FDA Finds Significant Bioequivalence Concerns in Raptim Studies Leading to ANDA and NDA Reviews

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In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) and new drug applications...more

Walkers

Data Protection in the British Virgin Islands

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The British Virgin Islands ("BVI") Data Protection Act, 2021 ("DPA") came into force on 9 July 2021. It was introduced so the BVI would have a data protection framework which is broadly similar to EU and UK standards. To...more

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