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US FDA announces training programmes for device review staff
08 September 2011
The US FDA is introducing two new training programmes to improve the consistency and skill of its medical device unit staff who review pre-market applications. The programmes, designed for reviewers at the FDA’s Center for Devices and Radiological ...
US FDA improves manufacturer evaluation codes for adverse event device reports
08 September 2011
The US FDA has improved the manufacturer evaluation codes that companies can use when submitting medical device adverse event reports, or MDRs, to the agency. The new codes are expected to help reduce manufacturer reporting burden, improve adverse ...
US FDA analysis blames poor quality 510(k) submissions for delays in reviews
28 July 2011
The time it takes for the US Food and Drug Administration to review 510(k) applications for clearing medical devices has increased because of industry's failure to file submissions of an adequate quality, an internal analysis by the FDA has ...
US FDA reopens opportunity to comment on reprocessing of reusable medical device
28 July 2011
The US Food and Drug Administration is giving stakeholders another chance to submit comments on factors affecting the reprocessing of reusable medical devices. The FDA has reopened the opportunity to comment after stakeholders were unable to respond ...
US FDA invites comments on introducing UDIs in electronic data healthcare systems
26 July 2011
The US Food and Drug Administration is to hold a workshop in which it will seek stakeholder feedback on the adoption, implementation and use of unique device identifiers in various health-related electronic data systems. Implementing UDIs in ...
 
Healthcare reform: it's not make or break 04 August 2009

President Barack Obama’s wish for the US healthcare system to be transformed by the end of July has not been fulfilled. But this is by no means disastrous, either for him or the US. Americans want the system to be reformed, and it will be. Just not ...

Cuba and the importance of not knowing
10 June 2009
"Corazón que no ve, corazón que no siente." What you – and your heart – don't see and don't know, won't hurt you, they say. The sentiment could not be more poignant than in the context of Cuban healthcare – it has a particular twist or two, of a ...
 
Off-label promotion: how to avoid falling foul of the US FDA
18 February 2011
Off-label use of medical devices happens so often that it has become the standard of care for some disorders. But the FDA's rules on off-label use of devices are labyrinthine – and its edicts on off-label use versus off-label promotion can ...
AABB 2010: IVD innovation continues in transfusion medicine despite challenging environment
10 January 2011
The unprecedented economic conditions and impending healthcare reform measures in the US cast a mood of uncertainty over this year's American Association of Blood Banks (AABB) conference. However, this has not stemmed the flow of innovation among ...
Review of 2009: Testing times for cancer screening
28 January 2010
Screening programmes to detect cancer in its early stages came under the spotlight last year as healthcare providers sought to restrict their reach, causing public outrage. Madeleine Armstrong considers the pros and cons of screening for breast, ...
 
Adalimumab for the treatment of severe psoriasis and psoriatic arthritis
Backround: Psoriasis is a chronic, genetically determined, immunomediated, inflammatory skin disease affecting ∼ 2 – 3% of the Caucasian population. Systemic treatment is required in moderate to severe plaque-type psoriasis forms or psoriatic ...
Regulation of the Na + /H + exchanger in the healthy and diseased myocardium
13 May 2009
Background: Na + /H + exchangers (NHE's) are membrane proteins that regulate ion fluxes, they extrude one intracellular proton in exchange for one extracellular sodium thereby regulating intracellular pH. Mammalian NHE's have nine isoforms, ...
Pharmacotherapy of age-related macular degeneration
12 May 2009
Background: Age-related macular degeneration is the leading cause of blindness in the developed world. The number of persons with vision loss from age-related macular degeneration is projected to increase dramatically over the next few decades. ...
 
 
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