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27 April 2011

The US Food and Drug Administration has announced a review of all its existing drug, medical device, food and tobacco regulations to determine whether they can be made more effective in light of current public health needs and to support advances in ...

07 January 2011

Belén Crespo Sánchez-Eznarriaga has been appointed director of the Spanish healthcare products regulatory agency, the AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) 1 . Ms Crespo replaces Cristina Avendaño, who had held the post ...

06 January 2011

The US Food and Drug Administration's principal deputy commissioner, Joshua Sharfstein , is leaving the agency to take the reins of the Maryland Department of Health and Mental Hygiene, the state's governor has revealed 1 . Dr Sharfstein’s first day ...

HTA
23 October 2009

The New Zealand medtech industry association, the MTANZ , has called for the introduction of a regulatory system that would involve the unilateral recognition of medical devices that have been approved for marketing in at least one of the five ...

09 September 2009

The UK Department of Health , after reviewing the performance of the Medicines and Healthcare products Regulatory Agency , has concluded that the agency needs to become more responsive to the needs of its stakeholders 1 ,2 . The review was carried ...

27 April 2011

The US Food and Drug Administration has announced a review of all its existing drug, medical device, food and tobacco regulations to determine whether they can be made more effective in light of current public health needs and to support advances in ...

11 January 2011

A UK parliamentary report has criticised the government's plan to dissolve or merge several public bodies, including many health-related bodies such as the Human Tissue Authority, the Human Fertilisation and Embryology Authority and the Human ...

01 March 2011

The EU Council of Ministers has approved new legislation on cross-border healthcare and promoting co-operation on healthcare between member states. The directive 1 , which includes amendments from the European Parliament , will affect the medtech ...

06 October 2009

The US government has issued new regulations aimed at improving the protection of the genetic information of individuals undergoing genetic testing 1 ,2 . The regulations, issued on 1 October via an interim final rule, aim to help ensure that ...

 
27 April 2011
Ashley Yeo
With the US in mid-regulatory review, stakeholders are keenly pushing for a safer and faster system, but there are different views on how these goals should be achieved. That was shown at a hearing of the US Senate's Special Committee on Aging 1 . ...
 
 
24 April 2009
The large number of people who attended the European Medicines Agency ’s first workshop on advanced therapy medicinal products reflects the interest ...
09 April 2009
The practice of companies showering doctors with gifts is on the way out in the US, the world’s biggest market for medical devices. Europe’s agency ...
02 April 2009
A key area for the development of nanotechnology is in medicines and medical devices. The application of nanotechnology to health, sometimes referred ...
08 October 2009
Please give details of the major acts and directives governing trademarks. Trademarks are governed in Luxembourg by the: Benelux Convention on ...
08 October 2009
1) Which authority is responsible for overseeing the regulation of medical devices and diagnostics in Spain? Agencia Española del Medicamento, the ...
RAJ Devices News Roundup, 11 December 2009
28 July 2011
 
Pharmacist takes the helm of Spanish regulator Belén Crespo Sánchez-Eznarriaga has been appointed director of the Spanish healthcare products regulatory agency, the AEMPS (Agencia Española de ...
 
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