Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union
Sign Up to like & getrecommendations! Published in 2018 at "Journal of Tissue Engineering and Regenerative Medicine"
DOI: 10.1002/term.2428
Abstract: Legislation for expedited‐approval pathways and programmes for drugs, biologics or medical devices has been enacted for rapid commercialization of innovative products in the United States of America (USA) and the European Union (EU). However, less… read more here.
Keywords: medicine; expedited approval; legislation expedited; approval ... See more keywords
The US Food and Drug Administration’s expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation
Sign Up to like & getrecommendations! Published in 2018 at "Clinical Trials"
DOI: 10.1177/1740774518770657
Abstract: When the editors of Clinical Trials solicited our review on the U.S. Food and Drug Administration’s (FDA) expedited development and review programs, we anticipated there would be accompanying commentaries from other academics with differing opinions,… read more here.
Keywords: approval programs; expedited approval; evidence; food drug ... See more keywords