The US Food and Drug Administration has released the results of a study that was conducted in support of the agency's plans to establish standards for drug sponsors with regard to communicating a medicine's side effects clearly in TV advertisements ...

A new guideline from the European Commission represents the first single, collated document to shed light on the role of the medical device authorised representative, the EU-based person or a body that medical device manufacturers need to have if ...

The European Commission is looking at "immediate measures" to improve the surveillance of medical devices within the existing legal framework in light of the sub-standard PIP breast implants affair 1 . The commission will launch a discussion with ...

Priorities for the European Medicines Agency in the drug safety area this year include a new urgent referral procedure, guidance on post-authorisation efficacy studies and more effective ways of detecting and acting on significant safety signals. ...

France's drug regulatory agency, Afssaps , has published details of the new membership of its various bodies and committees, including those responsible for drug approvals and pharmacovigilance 1 ,2 . The move is noteworthy because the ...

The US Food and Drug Administration has released the results of a study that was conducted in support of the agency's plans to establish standards for drug sponsors with regard to communicating a medicine's side effects clearly in TV advertisements ...

A new guideline from the European Commission represents the first single, collated document to shed light on the role of the medical device authorised representative, the EU-based person or a body that medical device manufacturers need to have if ...

The European Commission is looking at "immediate measures" to improve the surveillance of medical devices within the existing legal framework in light of the sub-standard PIP breast implants affair 1 . The commission will launch a discussion with ...

France's drug regulatory agency, Afssaps , has published details of the new membership of its various bodies and committees, including those responsible for drug approvals and pharmacovigilance 1 ,2 . The move is noteworthy because the ...

A new guideline from the European Commission represents the first single, collated document to shed light on the role of the medical device authorised representative, the EU-based person or a body that medical device manufacturers need to have if ...

The US Food and Drug Administration has "in principle" reached an agreement with the medtech industry to establish a faster, more predictable and transparent product review process in return for companies paying more than double the money ($595 ...

France's drug regulatory agency, Afssaps , has published details of the new membership of its various bodies and committees, including those responsible for drug approvals and pharmacovigilance 1 ,2 . The move is noteworthy because the ...

France's drug regulatory agency, Afssaps , has published details of the new membership of its various bodies and committees, including those responsible for drug approvals and pharmacovigilance 1 ,2 . The move is noteworthy because the ...

The US Food and Drug Administration has released the results of a study that was conducted in support of the agency's plans to establish standards for drug sponsors with regard to communicating a medicine's side effects clearly in TV advertisements ...

Priorities for the European Medicines Agency in the drug safety area this year include a new urgent referral procedure, guidance on post-authorisation efficacy studies and more effective ways of detecting and acting on significant safety signals. ...

France's drug regulatory agency, Afssaps , has published details of the new membership of its various bodies and committees, including those responsible for drug approvals and pharmacovigilance 1 ,2 . The move is noteworthy because the ...

Even as the EU and India continue negotiations on a free trade agreement ahead of their next summit in February, another in transit consignment of Indian generics was seized in the EU late last year, much to the consternation of both the Indian ...

The General Court of the European Union (formerly the EU Court of First Instance) has upheld a European Medicines Agency decision to deny Nycomed a waiver for a paediatric investigation plan (PIP) for its ultrasound echocardiographic imaging agent ...

The US Food and Drug Administration's unusually short meeting on 16 December to discuss the agency?s proposed recommendations for a biosimilars user fee programme saw a handful of industry and other stakeholders getting straight to the point with ...