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20 October 2014

 
20 October 2014

India is expected to announce significant amendments to its controversial trial compensation rules including clarifications on payments in case of injury or death due to an investigational medicinal product not having its intended therapeutic ...

17 October 2014

Four regulatory bodies in the UK have joined hands to offer combined advice to companies and other organizations working on regenerative medicines 1 . The initiative is a new a "one stop shop" service to help companies get a single response from the ...

17 October 2014

The US Food and Drug Administration has made four new entries and some other modifications to the list of medical device standards that the agency recognizes for use in pre-market reviews 1 . The new entries on the list comprise two general ...

16 October 2014

The European Medicines Agency is attempting to clarify what information drug companies should include in their marketing authorization dossiers to justify the selection of starting materials in light of 2012 International Conference on Harmonisation ...

20 October 2014

India is expected to announce significant amendments to its controversial trial compensation rules including clarifications on payments in case of injury or death due to an investigational medicinal product not having its intended therapeutic ...

17 October 2014

Four regulatory bodies in the UK have joined hands to offer combined advice to companies and other organizations working on regenerative medicines 1 . The initiative is a new a "one stop shop" service to help companies get a single response from the ...

17 October 2014

The US Food and Drug Administration has made four new entries and some other modifications to the list of medical device standards that the agency recognizes for use in pre-market reviews 1 . The new entries on the list comprise two general ...

16 October 2014

The European Medicines Agency is attempting to clarify what information drug companies should include in their marketing authorization dossiers to justify the selection of starting materials in light of 2012 International Conference on Harmonisation ...

20 October 2014

India is expected to announce significant amendments to its controversial trial compensation rules including clarifications on payments in case of injury or death due to an investigational medicinal product not having its intended therapeutic ...

17 October 2014

Four regulatory bodies in the UK have joined hands to offer combined advice to companies and other organizations working on regenerative medicines 1 . The initiative is a new a "one stop shop" service to help companies get a single response from the ...

17 October 2014

The US Food and Drug Administration has made four new entries and some other modifications to the list of medical device standards that the agency recognizes for use in pre-market reviews 1 . The new entries on the list comprise two general ...

16 October 2014

The European Medicines Agency is attempting to clarify what information drug companies should include in their marketing authorization dossiers to justify the selection of starting materials in light of 2012 International Conference on Harmonisation ...

15 October 2014

The Australian government will soon amend its regulations to allow most local medical device manufacturers to rely on conformity assessments by European notified bodies. The change is welcome news for the industry, which has long been pushing for a ...

15 October 2014

Johnson & Johnson/MSD's Remicade (infliximab) is to be made available to French patients for the unapproved indication of Takayasu's arteritis refractory to conventional drugs, under a temporary use recommendation (RTU) 1 . Remicade is the third ...

06 October 2014

All enterprises must disclose administrative penalty information in a timely manner or face a ban from public procurement, China has said. The rule could significantly change risk profiles for multinational healthcare companies in the country, say ...

06 October 2014

There have been complaints aimed at the US Centers for Medicare & Medicaid Services' launch of its so-called "Open Payments" system, an online database of drug and medical device manufacturers' financial interactions with physicians, which is ...

06 October 2014

All enterprises must disclose administrative penalty information in a timely manner or face a ban from public procurement, China has said. The rule could significantly change risk profiles for multinational healthcare companies in the country, say ...

01 October 2014

GlaxoSmithKline's Chinese bribery scandal ? which last month ended with the UK major being fined a record sum of nearly $490 million ? has left the pharma industry pondering its next steps to meet a rising bar and the soaring costs of compliance 1 . ...

29 September 2014

The European Medicines Agency is hoping to get a final decision from its management board on 2 October on its eagerly-awaited policy on proactive publication of clinical trial data. If things go as planned, the policy could come into effect next ...

 
09 October 2014
Dr Peter Charlish
Personalized medicine may not yet be a reality but, as a meeting of the Society for Medicines Research heard in London last week 1 , considerable progress has nonetheless already been made towards that goal. In the UK, for example, a number of ...
 
11 February 2014
Maureen Kenny
?If you don?t finance it correctly, it will implode.? This was the stark warning key European drug ...
 
07 October 2014
Marcus Deans, Mark A De Rosch and Emmanuelle Voisin emphasize that having a combined regulatory and ...
07 October 2014
It may still be several years before the European Commission's proposed regulation for medical ...
02 October 2014
Andy Vaughan discusses how the latest EU environmental legislation developments will impact medical ...
 
MOST READ
 
12 November 2013
Joint assessments by national designating authorities in the EU of notified bodies active in the medical device area are relatively new. A voluntary ...
28 August 2013
Ken Daly looks to the US to predict what could happen in Europe if the European Commission's recommendation for an EU-wide class action system is ...
05 July 2013
The French medtech market is already highly regulated and complex and is becoming more so. While the CE marking should act as a single passport to ...
 
A candid look at the European drug regulatory network from Jytte Lyngvig, CEO of the Danish Medicines Agency 2000-2012
18 January 2013
 
US FDA's drugs center gets permanent regulatory policy head The US Food and Drug Administration has promoted Grail Sipes to permanent director of its Office of Regulatory Policy at ...
Law enforcement expert named as new compliance chief at US FDA drug center The US Food and Drug Administration has hired Cynthia Schnedar as the new head of compliance at its Center for Drug ...
 
   
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