id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-296493-l437zwvt	Lumpkin, Murray M	Pandemic Best Regulatory Practices: An Urgent Need in the Covid‐19 Pandemic	2020-06-04		.txt	text/plain	1793	96	43	As large numbers of candidate drugs and vaccines for potential use in the Covid‐19 pandemic are investigated, medicines regulators globally must now make urgent, informed, contextually risk‐based decisions regarding clinical trials and marketing authorizations. As large numbers of candidate drugs and vaccines for potential use in the Covid-19 pandemic are investigated, medicines regulators globally must now make urgent, informed, contextually riskbased decisions regarding clinical trials and marketing authorizations. We lay out the critical role of regulators in the current crisis and offer eight "pandemic best regulatory practices." These should support both the regulatory public heath imperative and assure timely patient access to effective, safe, quality products worldwide during this emergencythus contributing to ending this pandemic as quickly, effectively, and safely as possible. There is pressure on the world's leading national regulatory authorities (NRAs) for medicines and medical devices to take urgent, informed, contextually risk-based decisions regarding clinical trials authorizations, emergency use authorizations, site inspections, and post-authorization commitments.	./cache/cord-296493-l437zwvt.txt	./txt/cord-296493-l437zwvt.txt