Elements of Regulatory Dissonance: Examining FDA and EMA Product Labeling of New Vaccines (2006-2018).

ABSTRACT: With the ongoing globalization of the pharmaceutical industry, efforts to harmonize technical requirements of registering drugs and biologics, including vaccines, have produced a number of useful guidelines utilized around the world. However, such efforts have not been extended to the regulatory review process or product labeling. Prescribing information and patient information leaflet are two types of such product labeling documents. This study examined the differences in the languages of these documents between the United States (US) and European Union (EU). 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 (EM

SUBMITTER: Seo Y 

PROVIDER: S-EPMC7550305 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature