id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-313423-g50oh15t	Lynch, Holly Fernandez	Emergency Approvals for COVID-19: Evolving Impact on Obligations to Patients in Clinical Care and Research	2020-11-03		.txt	text/plain	1145	65	46	There currently is debate regarding whether U.S. institutions and clinicians may or should restrict patient access to COVID-19 drugs and vaccines that have been granted emergency use authorization by the U.S. Food and Drug Administration. Traditional FDA approval typically supports clinical adoption of new standards of care because approval reflects a determination that a product's benefits outweigh its risks on the basis of a demonstration of safety and substantial evidence of effectiveness, a higher threshold than that required for an EUA. Despite concerns about whether that approval was warranted, given the data existing when the EUA was granted and consensus guidelines recommending remdesivir's use, failing to offer the drug (when available) might have been viewed as improperly withholding an intervention from which severely ill patients could expect to benefit. In contrast, if an EUA is based on weak evidence, such as observational data or uncontrolled trials-as in the case of convalescent plasma-institutions and clinicians can reasonably decline to offer the product without wronging eligible patients (8) .	./cache/cord-313423-g50oh15t.txt	./txt/cord-313423-g50oh15t.txt