Electrophysiology devices and the regulatory approval process within the U.S. FDA and abroad
Sign Up to like & getrecommendations! Published in 2019 at "Journal of Interventional Cardiac Electrophysiology"
DOI: 10.1007/s10840-019-00607-x
Abstract: Almost all electrophysiology (EP) devices need to obtain premarket approval before they can be commercially sold and available for use in the community. The US Food and Drug Administration (FDA) has different paths to market… read more here.
Keywords: regulatory approval; approval process; devices regulatory; electrophysiology devices ... See more keywords
Regulatory Approval and Practice Guidelines Involving Cardiovascular Valve Devices: Determining the Right Evidentiary Bar.
Sign Up to like & getrecommendations! Published in 2020 at "Journal of the American College of Cardiology"
DOI: 10.1016/j.jacc.2020.06.057
Abstract: Randomized clinical trials (RCTs) are one of the foundations of evidence generation to determine the safety and effectiveness of new therapies in the cardiovascular device arena. They serve as the highest level of evidence for… read more here.
Keywords: regulatory approval; involving cardiovascular; approval practice; guidelines involving ... See more keywords
Impression management strategies to gain regulatory approval
Sign Up to like & getrecommendations! Published in 2019 at "Journal of Business Research"
DOI: 10.1016/j.jbusres.2019.08.006
Abstract: Abstract Using fuzzy-set Qualitative Comparative Analysis and data from the U.S. liquefied natural gas (LNG) import industry (2000−2013), I explore the complex configurations of conditions that impact regulatory approval and approval speed for a new… read more here.
Keywords: impression management; approval; regulatory approval; management strategies ... See more keywords
Hepatitis B cure: From discovery to regulatory approval.
Sign Up to like & getrecommendations! Published in 2017 at "Journal of hepatology"
DOI: 10.1016/j.jhep.2017.05.008
Abstract: The majority of persons currently treated for chronic hepatitis B require long-term or lifelong therapy. New inhibitors of hepatitis B virus entry, replication, assembly, or secretion and immune modulatory therapies are in development. The introduction… read more here.
Keywords: regulatory approval; hepatitis; cure; discovery regulatory ... See more keywords
Fast-tracking development and regulatory approval of COVID-19 vaccines in the EU: A review of ethical implications.
Sign Up to like & getrecommendations! Published in 2023 at "Bioethics"
DOI: 10.1111/bioe.13151
Abstract: The rapid spread of SARS-CoV-2 worldwide has triggered intense activity in the field of biotechnology, leading to the development and regulatory approval of multiple COVID-19 vaccines in less than 1 year while raising sustained scrutiny as… read more here.
Keywords: development regulatory; development; covid vaccines; regulatory approval ... See more keywords
Regulatory Approval With Real-World Data From Regulatory Science Perspective in Japan
Sign Up to like & getrecommendations! Published in 2022 at "Frontiers in Medicine"
DOI: 10.3389/fmed.2022.864960
Abstract: Recently, there has been a growing trend in clinical development to utilize real-world data (RWD) to improve the efficiency of drug/medical device development. Especially, the use of RWD to generate real-world evidence (RWE) in regulatory… read more here.
Keywords: approval; world data; regulatory approval; japan ... See more keywords