Email ID
Password
Sign me in automatically next time
RECENT TWEETS    
26 April 2015

 
24 April 2015

The chair of the European Medicines Agency's management board has moved to provide reassurance that the current high rate of turnover among heads of national medicines agencies in Europe has had no negative effect on the overall effectiveness of the ...

24 April 2015

The Food and Drug Administration's draft guideline on acceptance of medical device clinical trial data from studies conducted outside the US (OUS) is a positive for the industry and shows the US agency's increased willingness to be flexible on this ...

24 April 2015

A new management board is in place at the Greek medicines regulatory agency, EOF 1 , and an acting director has been appointed at the Slovenian medicines and medical devices agency, the JAZMP 2 . This brings to least nine the number of national ...

24 April 2015

The US Food and Drug Administration's breakthrough therapy designation (BTD) is working as intended ? speeding new innovative drugs to patients sooner than otherwise would be the case without the status. But a new analysis also shows the designation ...

24 April 2015

The chair of the European Medicines Agency's management board has moved to provide reassurance that the current high rate of turnover among heads of national medicines agencies in Europe has had no negative effect on the overall effectiveness of the ...

24 April 2015

The Food and Drug Administration's draft guideline on acceptance of medical device clinical trial data from studies conducted outside the US (OUS) is a positive for the industry and shows the US agency's increased willingness to be flexible on this ...

24 April 2015

A new management board is in place at the Greek medicines regulatory agency, EOF 1 , and an acting director has been appointed at the Slovenian medicines and medical devices agency, the JAZMP 2 . This brings to least nine the number of national ...

24 April 2015

The US Food and Drug Administration's breakthrough therapy designation (BTD) is working as intended ? speeding new innovative drugs to patients sooner than otherwise would be the case without the status. But a new analysis also shows the designation ...

24 April 2015

The Food and Drug Administration's draft guideline on acceptance of medical device clinical trial data from studies conducted outside the US (OUS) is a positive for the industry and shows the US agency's increased willingness to be flexible on this ...

24 April 2015

The US Food and Drug Administration's breakthrough therapy designation (BTD) is working as intended ? speeding new innovative drugs to patients sooner than otherwise would be the case without the status. But a new analysis also shows the designation ...

22 April 2015

Representative Fred Upton (Republican-Michigan), chairman of the Energy and Commerce Committee of the US House of representatives, is hoping to have an agreement by the end of this month on a bill aimed at overhauling the US biomedical ...

22 April 2015

The World Health Organization is inviting feedback on its plans to levy a new annual fee on drugs, vaccines, medical devices and in vitro diagnostics evaluated through its pre-qualification program, which is widely used by procurement agencies such ...

21 April 2015

The World Health Organization is making public all suspected adverse drug reaction reports stored in its global pharmacovigilance database VigiBase that is maintained by the Uppsala Monitoring Centre in Sweden 1 ,2 . VigiBase currently has ...

17 April 2015

John Castellani announced on16 April that he plans to step down as CEO of US drug industry association Pharmaceutical Research and Manufacturers of America (PhRMA) at the end of the year. The revelation at the drug industry lobbying group's board ...

17 April 2015

The Transatlantic Trade and Investment Partnership (TTIP) could lead to common standards in areas like the safety of medicines and medical devices, but it must not "sacrifice certain European safeguards on the altar of free trade", an influential ...

15 April 2015

As evidence accumulates on the use of biosimilars in the real-world setting, it looks as if regulatory agencies in Europe may be softening their stance on interchangeability after the Dutch regulator the MEB came out in favor of allowing patients ...

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 ...

11 March 2015

The Court of Justice of the European Union has delivered a preliminary ruling on defective medical devices that could introduce new costs for manufacturers. The CJEU ruled that where a medical device has a potential defect based on quality control ...

 
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 ...
 
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 ...
01 April 2015
There are now three bases on which clinical data can be disclosed in the EU. Elisabethann Wright, ...
 
 
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 ...
 
   
© 2015 Informa plc. All rights reserved.
This site is owned and operated by Informa plc ("Informa") whose registered office is Mortimer House, 37-41 Mortimer Street, London, W1T 3JH. Registered in England and Wales. Number 3099067. UK VAT Group: GB 365 4626 36