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Regions - US
Industry gives nod to doubling of US FDA user fees - in exchange for improved approval process
02 February 2012
US medtech industry association AdvaMed has reached a tentative user fee agreement with the FDA in which companies would pay the agency twice as much to have their products evaluated, in exchange for a faster and more predictable review process. The ...
US FDA's device ombudsman reports 11% increase in contacts in 2011
31 January 2012
The ombudsman for the US FDA's medical device centre in 2011 received 461 requests, or "contacts", from stakeholders to resolve various issues. The number of contacts received in 2011 represents an overall increase of 11% as compared to 2010, when ...
US FDA sets 30 June deadline for finalising companion Dx guidance
26 January 2012
The US FDA's guideline on the development of companion diagnostics is expected to be finalised by 30 June, the agency has announced in a document outlining its medical device unit's strategic priorities for 2012. A draft version of the guideline, ...
US FDA misses deadline for submitting device user fee proposal to Congress
24 January 2012
The US Food and Drug Administration has missed its 15 January deadline for submitting a plan to Congress on how much user fees the medical device industry should pay the agency to evaluate its products in fiscal years 2013-2017. The FDA's current ...
US FDA plans public workshop on evaluating medtech, pharma countermeasures for children
20 January 2012
The US Food and Drug Administration is to host a public workshop on the ethical and regulatory challenges associated with evaluating whether medical countermeasures developed to deal with public health emergencies are safe and effective in the ...
 
Companion Dx activity shines new light on IVD sector - is it all good?
04 January 2012
Developments on the regulatory and business front in the area of companion diagnostics made 2011 a pivotal year for both personalised medicine as a concept and for IVD manufacturers as a group. But might stricter regulation hinder testing in ...
Clinica 100: What lies ahead for US device regulation
01 December 2011
The jury is still out as to how the US regulatory system is going to evolve in the long term, but change it will. As the FDA gathers feedback on the IOM's damning report on the 510(k) system and the recommended changes, Glenn Neuman, director of ...
First we take Europe, then the US – the irresistible rise of China 18 January 2011

A new report on the medtech innovation potential of countries around the world confirms a long-held suspicion: the emerging markets of China and India are gaining on the US. This has been the consensus view based on informed speculation for several ...

 
US healthcare reform: How it could impact your business
16 August 2011
The US market is the largest and arguably the world’s most attractive medical market. But healthcare reforms which were enacted last year will bring about change. Edward Berger of Larchmont Strategic Advisors and Robert Keefer of TCG Medtech explain ...
New guidance from the US FDA may mean just one thing for medical device manufacturers - more 510(k)s
02 August 2011
The FDA’s new draft guidance on when to submit a 510(k) for a change to an existing device appears to suggest that many more modifications will necessitate a new 510(k) than was previously the case, says Jennifer D Newberger. At first glance, the ...
Complaint handling: a window into the soul of your quality system 19 May 2011

An inadequate complaint handling system is a frequent shortcoming highlighted in FDA warning letters. Glenn Neuman of New World Regulatory Solutions gives some pointers on how to strengthen your quality system and overcome one of the most frequent ...

 
 
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EVENTS
The 14th MedTech Investing Europe conference
19 March 2012
Montreux Convention and Music Centre, Switzerland
HTAi 2012
23 June 2012
Bilbao, Spain
 
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