https://socictopen.socict.org/files/original/15623d2b7091ff1c0828bdc67a005eee.pdf 10f993719f7c3d6842d427ac412b1649 Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Coronavirus Description An account of the resource Dominio científico: Coronavirus Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Current regulatory approaches for accessing potential COVID-19 therapies Creator An entity primarily responsible for making the resource Armond Daci, Aleksandra Grozdanova, Milena Stevanovic, Irina Panovska-Stavridis, Vesa Halimi, Simona Stojanovska, Venko Filipce Description An account of the resource Abstract This commentary aims to elaborate challenges in the regulatory approaches for accessing and investigating COVID-19 potential therapies either with off-label use, compassionate use, emergency use or for clinical trials. Since no therapies have been formally approved and completely effective and safe to date, the best clinical choice is acquired only after consistent and fair communication and collaboration between licensed clinicians, researchers, regulatory authorities, manufacturers and patients. Date A point or period of time associated with an event in the lifecycle of the resource 2020 Subject The topic of the resource FDA, clinical studies, regulatory, EMA, Compassionate use, COVID-19 Identifier An unambiguous reference to the resource within a given context DOI: 10.1186/s40545-020-00222-6 Source A related resource from which the described resource is derived Journal of Pharmaceutical Policy and Practice Publisher An entity responsible for making the resource available BMC Coverage The spatial or temporal topic of the resource, the spatial applicability of the resource, or the jurisdiction under which the resource is relevant Therapeutics. Pharmacology, Pharmacy and materia medica