Document TypeAccepted Manuscript
Food and Drug Administration
randomized clinical trial
Bioethics and Medical Ethics
Pharmacy and Pharmaceutical Sciences
MetadataShow full item record
AbstractFDA is the gatekeeper to protect the public health and is critical to sustain US global leadership in drug innovation. Our foundation of evidence-based clinical practice is based on large, well-designed randomized controlled trials. The failure of HCQ against COVID-19 stands as prime example of the urgent need for adherence to science. Rigorous scientific objectivity Downloaded from https://academic.oup.com/ajhp/advance-article/doi/10.1093/ajhp/zxaa257/5879960 by Medical Center Library user on 17 August 2020 13 and independence must prevail in any future EUA decision by FDA. Trust in FDA’s mission to approve safe and effective medications was built over decades by the capable scientists working for the agency, and the integrity of public trust must be protected to conquer future pandemics and ensure safe use of vaccines against COVID-19 once they become available.
Guharoy R, Krenzelok E. Searching for COVID-19 treatments: First, do no harm. Am J Health Syst Pharm. 2020 Aug 3:zxaa257. doi: 10.1093/ajhp/zxaa257. Epub ahead of print. PMID: 32744592. Link to article on publisher's site
Permanent Link to this Itemhttp://hdl.handle.net/20.500.14038/27634
RightsThis work is written by (a) US Government employee(s) and is in the public domain in the US.