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In 2016, European companies doing business in the US were able to breathe a sigh of relief. The European Commission deemed the Privacy Shield to be an adequate privacy protection. For the next half a decade, this shield, as...more
On 21 June 2017, FDA announced the availability of a new draft guidance titled "Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11 — Questions and Answers." The draft guidance is...more