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References from Drugs and Devices. Local targets link to admitted publications; unresolved targets remain external evidence.
Comparison of drug approval process in United States and Europe
2013 · External reference
Contrasting clinical evidence for market authorisation of cardio-vascular devices in Europe and the USA: a systematic analysis of 10 devices based on Austrian pre-reimbursement assessments
10.1186/1471-2261-14-154 · 2014 · External reference
Regulation of medical devices in the United States and European Union
10.1056/nejmhle1113918 · 2012 · External reference
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Regulation of medicines and medical devices: contrasts and similarities
10.7861/clinmedicine.14-1-6 · 2014 · External reference
Drugs, devices and the FDA: an overview of approval processes. Part 1 FDA approval processes for drugs
2016 · External reference
Drugs, devices and the FDA: an overview of approval processes. Part 2 FDA approval of medical devices
2016 · External reference
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2006 · External reference
Regulatory review of novel therapeutics—comparison of three regulatory agencies
10.1056/nejmsa1200223 · 2012 · External reference
Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe
10.1377/hlthaff.2011.0231 · 2011 · External reference
Publication bias: a problem in interpreting medical data
10.2307/2982993 · 1988 · External reference
Unresolved reference
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How useful are unpublished data from the Food and Drug Administration in meta-analysis?
10.1016/s0895-4356(02)00520-6 · 2003 · External reference
Opening up data at the European Medicines Agency
10.1136/bmj.d2686 · 2011 · External reference
Regulation and safe adoption of new medical devices and procedures
10.1093/bmb/ldt022 · 2013 · External reference
European medical device regulatory law and product liability
10.1016/s0195-6701(99)90083-x · 1999 · External reference
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Improving medical device regulation: the United States and Europe in perspective
10.1111/1468-0009.12043 · 2014 · External reference
Registration and regulation of medical devices used in diabetes in Europe: need for radical reform
10.1016/s2213-8587(13)70178-5 · 2013 · External reference
The regulation of medical devices and the role of the Medical Devices Agency
10.1046/j.0306-5251.2001.01416.x · 2001 · External reference
Understanding the medical device directive changes
10.2345/0899-8205-43.4.319 · 2009 · External reference
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EU and member state medical device regulation
10.1017/s0266462303000217 · 2003 · External reference
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How a fake hip showed up failings in the European device regulation
10.1136/bmj.e7090 · 2012 · External reference
Medical device development: from prototype to regulatory approval
10.1161/01.cir.0000134695.65733.64 · 2004 · External reference
Europeans are left to their own devices
10.1136/bmj.d2748 · 2011 · External reference
The EU's system for regulating medical devices: now is the time for radical change
10.1136/bmj.e7126 · 2012 · External reference
The truth behind “made in Europe” labels on medical devices
10.1136/bmj.e7193 · 2012 · External reference
Devices and desires: industry fights toughening of medical device regulation in Europe
10.1136/bmj.f6204 · 2013 · External reference
How does medical device approval regulation perform in the United States and the European Union? A systematic review
10.1371/journal.pmed.1001276 · 2012 · External reference
Postmarketing surveillance of medical devices—filling in the gaps
10.1056/nejmp1114865 · 2012 · External reference
Patient access to medical devices—a comparison of U.S. and European review processes
10.1056/nejmp1204170 · 2012 · External reference
Only 3 in 20 new drugs approved in Germany in 2011 were an improvement, report says
10.1136/bmj.g2657 · 2014 · External reference
Commentary: the risk of over-regulation
10.1136/bmj.d3021 · 2011 · External reference
Medical devices and the approval processes: United States vs. France
10.1001/archinternmed.2010.454 · 2010 · External reference
The FDA approval process for medical devices: an inherently flawed system or a valuable pathway for innovation?
10.1136/neurintsurg-2012-010400 · 2013 · External reference
Review of the processes for FDA oversight of drugs, medical devices and combination products
10.18553/jmcp.2011.17.1.40 · 2011 · External reference
Medical device recalls and the FDA approval process
10.1001/archinternmed.2011.30 · 2011 · External reference
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The 501(k) ancestry of a metal-on-metal hip implant
10.1056/nejmp1211581 · 2013 · External reference
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2012 · External reference
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2009 · External reference
Medical devices–balancing regulation and innovation
10.1056/nejmp1109094 · 2011 · External reference
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The epidemiology of drug recalls in the United States
10.1001/archinternmed.2012.2013 · 2012 · External reference
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Trial watch: phase II and submission failures 2007-2010
10.1038/nrd3375 · 2011 · External reference
Can the pharmaceutical industry reduce attrition rates?
10.1038/nrd1470 · 2004 · External reference
Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma
10.1038/nrd2664 · 2008 · External reference
Paying for drug approval—who's using whom?
10.1056/nejmp078041 · 2007 · External reference
Approvals of drugs with uncertain benefit-risk profiles in Europe
10.1016/j.ejim.2015.08.008 · 2015 · External reference
Post marketing surveillance and vigilance for medical devices: the European approach
10.2165/00002018-200124120-00001 · 2001 · External reference
The Poly Implant Prosthèse breast prosthesis scandal: embodied risk and social suffering
10.1016/j.socscimed.2015.10.068 · 2014 · External reference
The saga of Poly Implant Prosthèse breast implants
10.1136/bmj.e306 · 2012 · External reference
Medical device regulation: time to improve performance
10.1371/journal.pmed.1001277 · 2012 · External reference
In search of the shocking truth
10.1016/j.hrthm.2012.05.005 · 2012 · External reference
Class I recall of defibrillator leads: a comparison of the Sprint Fidelis and Riata families
10.1016/j.hrthm.2012.04.003 · 2012 · External reference
Deaths caused by failure of Riata and Riata ST implantable cardioverter-defibrillator leads
10.1016/j.hrthm.2012.03.048 · 2012 · External reference
Here we go again—another failure of postmarketing device surveillance
10.1056/nejmp1114695 · 2012 · External reference
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Medical-device recalls in the UK and the device regulation process: retrospective review of safety notices and recalls
10.1136/bmjopen-2011-000155 · 2011 · External reference
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Assessment of cardiovascular and noncardiovascular medical device recalls
10.1016/j.amjcard.2014.03.024 · 2014 · External reference
The US Food and Drug Administration-European Medicines Agency collaboration in pharmacovigilance: common objectives and common challenges
10.1007/s40264-014-0259-3 · 2015 · External reference
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