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25 May 2015

 
22 May 2015

The European Medicines Agency is planning to expand the scope of its scientific advice service by formally including the expertise of its pharmacovigilance committee, PRAC, in the process 1 . To this end, it will soon launch a 12-month pilot project ...

22 May 2015

There is no respite for GVK Biosciences, the Indian contract research organization in the eye of a storm over allegations of data manipulation by European regulators. The European Medicines Agency said today it was sticking with its previous ...

21 May 2015

The US Food and Drug Administration's devices center says its draft guidance on adaptive designs 1 for clinical studies could help medical device manufacturers cut the cost of clinical trials. The proposal, released by the Center for Devices and ...

21 May 2015

An exploratory exercise by the Indian government on whether it should formally apply to join the pharmaceutical inspection and co-operation scheme (PIC/S) has resulted "in a lot of positive, open thinking" among concerned stakeholders, but no final ...

22 May 2015

The European Medicines Agency is planning to expand the scope of its scientific advice service by formally including the expertise of its pharmacovigilance committee, PRAC, in the process 1 . To this end, it will soon launch a 12-month pilot project ...

22 May 2015

There is no respite for GVK Biosciences, the Indian contract research organization in the eye of a storm over allegations of data manipulation by European regulators. The European Medicines Agency said today it was sticking with its previous ...

21 May 2015

The US Food and Drug Administration's devices center says its draft guidance on adaptive designs 1 for clinical studies could help medical device manufacturers cut the cost of clinical trials. The proposal, released by the Center for Devices and ...

21 May 2015

An exploratory exercise by the Indian government on whether it should formally apply to join the pharmaceutical inspection and co-operation scheme (PIC/S) has resulted "in a lot of positive, open thinking" among concerned stakeholders, but no final ...

22 May 2015

There is no respite for GVK Biosciences, the Indian contract research organization in the eye of a storm over allegations of data manipulation by European regulators. The European Medicines Agency said today it was sticking with its previous ...

21 May 2015

The US Food and Drug Administration's devices center says its draft guidance on adaptive designs 1 for clinical studies could help medical device manufacturers cut the cost of clinical trials. The proposal, released by the Center for Devices and ...

21 May 2015

An exploratory exercise by the Indian government on whether it should formally apply to join the pharmaceutical inspection and co-operation scheme (PIC/S) has resulted "in a lot of positive, open thinking" among concerned stakeholders, but no final ...

21 May 2015

Republican and Democratic leaders of the US House energy and commerce committee late on 20 May said they had reached a deal on how they will pay for the expected $13bn costs of implementing the provisions in the proposed 21st Century Cures Act (HR ...

22 May 2015

The European Medicines Agency is planning to expand the scope of its scientific advice service by formally including the expertise of its pharmacovigilance committee, PRAC, in the process 1 . To this end, it will soon launch a 12-month pilot project ...

21 May 2015

An exploratory exercise by the Indian government on whether it should formally apply to join the pharmaceutical inspection and co-operation scheme (PIC/S) has resulted "in a lot of positive, open thinking" among concerned stakeholders, but no final ...

21 May 2015

Switzerland?s healthcare product regulator, Swissmedic, is planning to replace the pharmacovigilance database it currently uses with a modern system by the end of 2017 and has issued a request for information on the project from software suppliers 1 ...

21 May 2015

Generics companies have several reservations about the European Medicines Agency's new literature monitoring service, under which the agency intends to check several reference databases and journals for suspected adverse reactions involving 400 ...

05 May 2015

For the US, India remains on the "priority watch list" of countries that presents the most significant intellectual property rights (IPR)-related concerns. However, it has been spared another immediate out-of-cycle review (OCR) in view of steps ...

23 April 2015

The Court of Justice of the European Union has been asked to decide whether medical device notified bodies can be held liable for patient safety if they fail to detect misconduct by a device manufacturer whose products they evaluated 1 . Should the ...

23 March 2015

A US District Court has ruled that Novartis unit Sandoz did nothing wrong by not engaging in the disclosure and dispute resolution process laid out by the Biologics Price Competition and Innovation Act ? the law that established the abbreviated ...

 
02 April 2015
Ian Schofield
News that the French regulatory agency ANSM has formally launched an internal inquiry into claims that former members of two committees responsible for decisions on drug approval and reimbursement held secret meetings with pharmaceutical companies ...
 
07 November 2014
Maureen Kenny
The appointment of Professor Sir Michael Rawlins as chair of the UK Medicines and Healthcare ...
 
20 May 2015
Patent expiries, pricing pressures and the emergence of approval pathways in countries such as ...
14 April 2015
Adam Sherlock discusses a recent life science industry survey that shows how companies are ...
02 April 2015
Daniel Kracov and Rosemary Maxwell explain how the 21 st Century Cures initiative proposes to ...
 
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 ...
 
The EMA at 20, what's it all about?
17 April 2015
 
EU electromedical industry association COCIR gets new president The European radiological, electromedical and healthcare IT industry association, COCIR, has appointed Joost Leeflang from ...
New MITA regulatory director to promote imaging standards adoption The US Medical Imaging & Technology Alliance has appointed Megan Hayes as its regulatory and standards director 1 . In her ...
 
   
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