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RECENT TWEETS    
28 June 2016

 
27 June 2016

The European Federation of Pharmaceutical Industries and Associations has welcomed most of the changes that the European Medicines Agency has proposed making to its guideline on risk management plans (RMPs), saying that the revisions would help ...

27 June 2016

June 24 was a seismic day, in more ways than one. The UK's decision to withdraw from the EU may have elated more than half of the voting public, but it has caused deep disappointment, anxiety and anger among many millions more in the UK, Europe and ...

27 June 2016

Pharmaceutical companies worried about how the UK's vote to leave the EU will affect their IP rights are being advised to 'keep calm and carry on' as instruments for securing patent protection in the UK will remain unaffected by the departure. ...

27 June 2016

The texts of the new EU medical device and IVD regulations have now been published in their likely final versions, save for the tweaking expected during the European Commission's legal review. Scrip Regulatory Affairs sister publication Clinica ...

27 June 2016

The European Federation of Pharmaceutical Industries and Associations has welcomed most of the changes that the European Medicines Agency has proposed making to its guideline on risk management plans (RMPs), saying that the revisions would help ...

27 June 2016

June 24 was a seismic day, in more ways than one. The UK's decision to withdraw from the EU may have elated more than half of the voting public, but it has caused deep disappointment, anxiety and anger among many millions more in the UK, Europe and ...

27 June 2016

Pharmaceutical companies worried about how the UK's vote to leave the EU will affect their IP rights are being advised to 'keep calm and carry on' as instruments for securing patent protection in the UK will remain unaffected by the departure. ...

27 June 2016

The texts of the new EU medical device and IVD regulations have now been published in their likely final versions, save for the tweaking expected during the European Commission's legal review. Scrip Regulatory Affairs sister publication Clinica ...

27 June 2016

The texts of the new EU medical device and IVD regulations have now been published in their likely final versions, save for the tweaking expected during the European Commission's legal review. Scrip Regulatory Affairs sister publication Clinica ...

23 June 2016

Medical device makers should be prepared to identify and consider specific differences between patients of varying ages, races and ethnicities, and incorporate queries about subgroups into clinical trial designs and reports supporting 510(k) and ...

22 June 2016

The Global Medical Device Nomenclature Agency is reflecting on how its future income may be impacted by a ruling contained within the new EU Medical Device and IVD Regulations 1 ,2 . The regulations suggest that the nomenclature to be used by ...

22 June 2016

The US Supreme Court has called for the Solicitor General's views in litigation between Amgen Inc. and Sandoz Inc. over the biosimilar launch notification and patent dance provisions of the biosimilars statute 1 . The request indicates the court is ...

27 June 2016

The European Federation of Pharmaceutical Industries and Associations has welcomed most of the changes that the European Medicines Agency has proposed making to its guideline on risk management plans (RMPs), saying that the revisions would help ...

27 June 2016

June 24 was a seismic day, in more ways than one. The UK's decision to withdraw from the EU may have elated more than half of the voting public, but it has caused deep disappointment, anxiety and anger among many millions more in the UK, Europe and ...

14 June 2016

The Paris Public Prosecutor has opened judicial proceedings against 'persons unknown' for manslaughter and unintentional injury in the case of the French Phase I trial that in January this year led to the death of one volunteer and caused ...

08 June 2016

The Australian government is facing something of an uphill struggle in convincing patients and healthcare professionals of the benefits of biosimilars, at least judging by a survey that has just been presented to the stakeholder reference group set ...

27 June 2016

June 24 was a seismic day, in more ways than one. The UK's decision to withdraw from the EU may have elated more than half of the voting public, but it has caused deep disappointment, anxiety and anger among many millions more in the UK, Europe and ...

27 June 2016

Pharmaceutical companies worried about how the UK's vote to leave the EU will affect their IP rights are being advised to 'keep calm and carry on' as instruments for securing patent protection in the UK will remain unaffected by the departure. ...

22 June 2016

The US Supreme Court has called for the Solicitor General's views in litigation between Amgen Inc. and Sandoz Inc. over the biosimilar launch notification and patent dance provisions of the biosimilars statute 1 . The request indicates the court is ...

 
27 June 2016
Ashley Yeo
June 23 2016 will go down in history for UK Prime Minister David Cameron : the day his decision to call the bluff of his Conservative Party?s anti-EU clique came back to bite him on the backside 1 . Ex-Prime Minister, we should say, as it turns ...
 
07 July 2015
Maureen Kenny
Regulators face a difficult balancing act in the debate over how to get innovative medicines to ...
 
21 June 2016
Lincoln Tsang, Silvia Valverde and Jacqueline Mulryne explore how healthcare product companies are ...
14 June 2016
Is it legal for distributors of specifically re-labeled medical devices to carry out parallel ...
08 June 2016
As the European Commission explores how to streamline its rules governing orphan medicines, ...
 
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Next AdvaMed Chief Is BIO Exec Scott Whitaker US medical device industry association AdvaMed has appointed Scott Whitaker as its next president and CEO 1 . Whitaker, ...
 
   
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