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This review examines the clinical data submitted in support of EUA for antiviral and anti\u2010inflammatory therapeutics for coronavirus disease 2019 (COVID\u201019) through December of 2021 and the resilience of the authorization as new clinical data arose subsequent to the authorization. In the vast majority of cases, EUA was supported by at least one well\u2010powered randomized controlled trial (RCT) where statistically significant efficacy was demonstrated. This included branded medications already approved for use outside of the context of COVID\u201019. When used, the standard of a single RCT seemed to provide adequate evidence of clinical efficacy, such that subsequent clinical studies generally supported or expanded the EUA of the therapeutic in question. The lone generic agent that was granted EUA (chloroquine\/hydroxychloroquine) was not supported by a well\u2010controlled RCT, and the EUA was withdrawn within 3 months time. This highlighted not only the ambiguity of the EUA standard, but also the need to provide avenues through which high quality clinical evidence for the efficacy of a generic medication could be obtained. Therefore, maintaining the clinical trial networks assembled during the COVID\u201019 pandemic could be a critical component of our preparation for future pandemics. Consideration could also be given to establishing a single successful RCT as regulatory guidance for obtaining an EUA.<\/jats:p>","DOI":"10.1111\/cts.13384","type":"journal-article","created":{"date-parts":[[2022,8,5]],"date-time":"2022-08-05T06:09:26Z","timestamp":1659679766000},"page":"2279-2292","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["A review of clinical efficacy data supporting emergency use authorization for <scp>COVID<\/scp>\u201019 therapeutics and lessons for future pandemics"],"prefix":"10.1111","volume":"15","author":[{"given":"Seo\u2010Hyun","family":"Yoo","sequence":"first","affiliation":[{"name":"Harvard College  Cambridge Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9844-247X","authenticated-orcid":false,"given":"Lauren","family":"Kim","sequence":"additional","affiliation":[{"name":"Harvard College  Cambridge Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michelle","family":"Lu","sequence":"additional","affiliation":[{"name":"Harvard College  Cambridge Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kira","family":"Nagoshi","sequence":"additional","affiliation":[{"name":"Harvard College  Cambridge Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5220-2275","authenticated-orcid":false,"given":"Mark\u00a0N.","family":"Namchuk","sequence":"additional","affiliation":[{"name":"Department of Biological Chemistry and Molecular Pharmacology Blavatnik Institute, Harvard Medical School  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,8,21]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/hed.26275"},{"key":"e_1_2_9_3_1","unstructured":"Emergency Use Authorization.U.S. Food and Drug Administration2021. 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