id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-308284-r546ypur	Simpson, Shmona	Navigating facilitated regulatory pathways during a disease X pandemic	2020-10-23		.txt	text/plain	7029	338	38	Several potential regulatory scenarios may exist and co-exist during an epidemic: for example, (a) de-novo candidates requiring rapid development and regulatory assessment (b) de-novo products requiring assessment when the typical package of clinical efficacy data may not be available, (c) approval of de novo or repurposed products for "emergency" use only in specific populations (d) for compassionate use in specific (e.g., "named") individuals of an unauthorized medicine (e) conditional or accelerated authorization before the completion of efficacy studies or, (f) use of a licensed product outside of its approved use (e.g., for another indication, dosage regimen, or population). Conditional term-limited approval 22 FDA's Expanded Access (EA) is a program designed for patients with an immediately life-threatening disease to access a product that has clinical trial data (putatively showing an acceptable benefit-risk profile)-but does not yet have marketing authorization.	./cache/cord-308284-r546ypur.txt	./txt/cord-308284-r546ypur.txt