FDA's commitment to transparency.

In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.

US Food and Drug Administration (FDA) Emergency Use Authorization: Glass Half Full or Glass Half Empty?

Recently, the US Food and Drug Administration (FDA) issued emergency use authorization (EUA) for convalescent plasma (CP) for the treatment of hospitalized patients with coronavirus disease 2019 based on a non-peer-reviewed, open-label, observational study. Issuance of an EUA without a proven randomized, controlled trial (RCT) sets a dangerous precedent since the premature action drives healthcare providers and patients away from RCTs that are essential for determining the efficacy and safety of CP. More caution should have been taken based on what was learned from the recent debacle related to the rescinded EUA of hydroxychloroquine and chloroquine, which were approved initially based on an anecdotal report.