id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-299323-riotkgj4	Seo, Yurim	Elements of Regulatory Dissonance: Examining FDA and EMA Product Labeling of New Vaccines (2006–2018)	2020-10-13		.txt	text/plain	3649	196	46	The key documents examined were the U.S. Food & Drug Administration's (FDA) Package Inserts (PIs), U.S. Centers for Disease Control and Prevention's (CDC) Vaccine Information Statements (VISs), and the European Medicines Agency's (EMA) Summary of Product Characteristics (SmPCs) and Package Leaflets (PLs). Although efforts by the International Council for Harmonization (ICH) to harmonize technical requirements for registering drugs and biologics have produced a number of useful guidelines that are used around the world, such efforts have not been extended to the regulatory review process or product labeling [1] . This study compared vaccine prescribing information and patient information leaflet languages between FDA/Centers for Disease Control and Prevention (CDC) and EMA. The centralized route allows companies to submit a single Marketing Authorization Application (MAA) to EMA that leads to the product's approval in all countries within the European Economic Area (i.e., the 27 member states of the EU plus Iceland, Liechtenstein and Norway).	./cache/cord-299323-riotkgj4.txt	./txt/cord-299323-riotkgj4.txt