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10.1016/j.vaccine.2020.09.067 http://scihub22266oqcxt.onion/10.1016/j.vaccine.2020.09.067 33059971!7550305!33059971     free     free     free Deprecated: Implicit conversion from float 219.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 219.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 219.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 219.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 219.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 219.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 219.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 253.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       Vaccine 2020 ; 38 (47): 7485-7489 Nephropedia Template TP {{tp|p=33059971|t=2020. Elements of Regulatory Dissonance: Examining FDA and EMA Product Labeling of New Vaccines (2006-2018) |pdf=|usr=}}{{33059971}} gab.com Text Elements of Regulatory Dissonance: Examining FDA and EMA Product Labeling of New Vaccines (2006-2018) JO: Vaccine http://www.kidney.de/pget.php?&tw=1&pmid=33059971 #FOAvip 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 (EMA) Summary of Product Characteristics (SmPCs) and Package Leaflets (PLs). Prescribing information and patient information leaflet languages were subsequently organized into ten and seven categories, respectively. Comparison of FDA PIs to EMA SmPCs showed little harmonization between the two regions, and CDC VISs to EMA PLs revealed even less. Twit Text FOAVip Elements of Regulatory Dissonance: Examining FDA and EMA Product Labeling of New Vaccines (2006-2018) ????Vaccine http://www.kidney.de/pget.php?&tw=1&pmid=33059971 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=33059971 #FOAvip English Wikipedia <ref>{{Cite pmid|33059971}}</ref> Elements of Regulatory Dissonance: Examining FDA and EMA Product Labeling of New Vaccines (2006-2018) #MMPMID33059971 Seo Y; Pacifici E Vaccine 2020[Nov]; 38 (47): 7485-7489 PMID33059971show ga 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 (EMA) Summary of Product Characteristics (SmPCs) and Package Leaflets (PLs). Prescribing information and patient information leaflet languages were subsequently organized into ten and seven categories, respectively. Comparison of FDA PIs to EMA SmPCs showed little harmonization between the two regions, and CDC VISs to EMA PLs revealed even less. |*Pharmaceutical Preparations[MESH] |*Vaccines[MESH] |Drug Approval[MESH] |Drug Labeling[MESH] |Humans[MESH] |Product Labeling[MESH] |United States[MESH]Elements of Regulatory Dissonance: Examining FDA and EMA Product Label(epmc).pdf DeepDyve Pubget Overpricing