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Policy & Regulation - Regulation
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 ...
GE Healthcare warns UK MPs: We lose focus on early diagnosis at our peril
26 July 2011
The NHS reform in England wends its way ever onwards. The “pause” is well in the background and the NHS Future Forum has delivered its verdict, but there is much more debate to come before Royal assent is granted to the troubled Health and Social ...
Australian panel recommends transparency overhaul at TGA
22 July 2011
Australia's Therapeutic Goods Administration's "should move away from the conservative approach that has characterised its actions in the past and recognise that it has a duty to collaborate with stakeholders to create a culture in which the ...
 
The search for solutions to radioisotope supply problems 08 October 2009

The current shortage in international supplies of technetium-99m (Tc-99m), the isotope used in more than 80% of diagnostic applications, together with concerns about the use of weapons-grade uranium (HEU) to make the related isotope molybdenum-99, ...

 
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 ...
Health technology purchasing: will a single selling strategy work?
10 January 2011
In the EU, policies relating to healthcare financing, as with procurement and reimbursement, are fragmented and their impact is insufficiently understood. Corinna Sorenson*, research officer in European Health Policy at the London School of ...
Winderler of change: medtech must prove its worth, insists German HTA chief
06 January 2011
2011 is already shaping up to be a pivotal year in Germany for reimbursement of innovative medical technology and for the industry’s relationship with IQWiG, the country's Institute for Quality and Efficiency in Health Care. All eyes are on new ...
 
 
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