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The Word Lab
Keeping industry professionals up-to-date with the latest news affecting life science translations
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Regulatory


The European Medicines Agency (EMA) Suffers Cyber Attack

The European Medicines Agency (EMA) Suffers Cyber Attack

BioNTech released a statement on December 9, 2020 that Pfizer and their COVID-19 vaccine documents was “unlawfully accessed” in a breach on the European Medical Agency’s (EMA) system. The severity of the attack was not divulged, however the EMA disclosed that...
FDA Breakthrough Designation Given to ReGelTec

FDA Breakthrough Designation Given to ReGelTec

ReGelTec, a medical device company out of Baltimore’s leading medical device HYDRAFIL, has received Breakthrough Designation from the U.S. Food and Drug Administration (FDA). The Breakthrough Device Program was created with intentions to expedite the...