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Regulatory Public Disclosure

Authors: Sam Hamilton, Janice Branson, Mimi Sundler, Katherine Tucker

Editorial In the first half of 2021, keeping up with the regional regulators’ activities on COVID-19 medicines became a competitive sport. FDA’s Emergency Use Authorizations (EUAs), EMA’s Conditional Marketing Authorisations, and Health Canada’s Interim Orders kept us all busy – if not doing, then reading. By late May 2021, the EU had approved remdesivir; conditionally approved two mRNA vaccines (Pfizer-BioNTech’s and Moderna’s) and two adenovirus vector vaccines (AstraZeneca’s and Janssen’s); had publicly disclosed the clinical documentation for the Moderna and Pfizer-BioNTech vaccines; and had endorsed dexamethasone.

Medical Writing. 2021;30(2):102–107

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