id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-256264-9pyn0l6w	Halimi, Vesa	Current regulatory approaches for accessing potential COVID-19 therapies	2020-05-16		.txt	text/plain	1504	73	38	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. There are several regulatory approaches for accessing potential therapies in COVID-19 and they can be classified as clinical trials, compassionate use, emergency use and off-label use (Table 1) [1] [2] [3] . Although terminology and modalities may not be identical, compassionate use programs demanding regulatory approval, informed consent and follow-up information are established in most countries [11, 12] , and can be used to facilitate the access of seriously ill COVID-19 patients that cannot have access in clinical studies. Having regard to the fact that the manufacturer Gilead was called from the licensed clinicians to provide Remdesivir to hospitalized COVID-19 patients under the compassionate use, since 25th January 2020, and based on the methodological issues found at Grein et al.'s paper [16] , it remains doubtful whether Gilead or regulatory authorities were not vulnerable toward this program.	./cache/cord-256264-9pyn0l6w.txt	./txt/cord-256264-9pyn0l6w.txt