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09 February 2016

 
09 February 2016

Following the announcement that the European Commission is to mobilize ?10m for research into the mosquito-borne Zika virus, the European Medicines Agency has set up a dedicated expert task force to offer advice on R&D programs for medicines and ...

09 February 2016

The US Food and Drug Administration has adopted all of the recommendations that consulting firm Booz Allen Hamilton has made in the past two years to improve its medical device review process, but it is still too early to say if the changes have ...

08 February 2016

The World Health Organization is looking for an outside body to assess the expected impact of its planned 'biological qualifier' for biological medicines (BQ) on stakeholders because of the many divergent opinions that have been expressed over the ...

08 February 2016

The US Food and Drug Administration says most combination products only require a simulated-use human factors study, but some higher-risk products may require actual-use studies that include patient feedback to help the agency understand how the ...

09 February 2016

Following the announcement that the European Commission is to mobilize ?10m for research into the mosquito-borne Zika virus, the European Medicines Agency has set up a dedicated expert task force to offer advice on R&D programs for medicines and ...

09 February 2016

The US Food and Drug Administration has adopted all of the recommendations that consulting firm Booz Allen Hamilton has made in the past two years to improve its medical device review process, but it is still too early to say if the changes have ...

08 February 2016

The World Health Organization is looking for an outside body to assess the expected impact of its planned 'biological qualifier' for biological medicines (BQ) on stakeholders because of the many divergent opinions that have been expressed over the ...

08 February 2016

The US Food and Drug Administration says most combination products only require a simulated-use human factors study, but some higher-risk products may require actual-use studies that include patient feedback to help the agency understand how the ...

09 February 2016

Following the announcement that the European Commission is to mobilize ?10m for research into the mosquito-borne Zika virus, the European Medicines Agency has set up a dedicated expert task force to offer advice on R&D programs for medicines and ...

08 February 2016

The World Health Organization is looking for an outside body to assess the expected impact of its planned 'biological qualifier' for biological medicines (BQ) on stakeholders because of the many divergent opinions that have been expressed over the ...

08 February 2016

The US Food and Drug Administration says most combination products only require a simulated-use human factors study, but some higher-risk products may require actual-use studies that include patient feedback to help the agency understand how the ...

08 February 2016

Biotrial, the French CRO that conducted the Phase I study of Bial's FAAH inhibitor BIA 10-2474, has taken issue with a government inspection report that questioned its decision to continue dosing of the drug after one of the volunteers was taken to ...

05 February 2016

It is well known that biological medicinal products are different from chemically synthesized medicines and that these differences are recognized in terms of the data required to support their evaluation. Regulatory authorities are now ramping up ...

02 February 2016

The European Medicines Agency's pharmacovigilance committee, PRAC, could be ready to start holding public hearings to support the safety review of certain medicines on the market by the second half of this year. The hearings, when in place, will ...

02 February 2016

As part of its efforts to increase the use of biosimilar medicines, the Australian government is setting up a steering group to oversee the implementation of its 'Biosimilar Awareness Initiative', and a new stakeholder group to advise on key issues ...

29 January 2016

As of Feb. 1, marketing authorization holders operating in the EU will no longer have to submit type IA variations to notify the competent authorities of any changes they make relating to their qualified person responsible for pharmacovigilance ...

27 January 2016

The European Commission is examining the supplementary protection certificate (SPC) system for pharmaceuticals to see whether it is still workable, what its failings are, and whether a new EU-wide SPC might be needed in view of the imminent ...

22 January 2016

India has reported progress in discussions with European Union regulators over a ban by the European Commission on hundreds of Indian generic equivalents of off-patent drugs due to testing quality issues. The commission last July told its 28 member ...

18 January 2016

New EU rules on trade marks have come into force as part of a drive to align practices at member state and EU level, make the trade mark system more efficient and easier to use, and reduce the cost of registering marks, especially for smaller ...

 
16 December 2015
Amanda Maxwell
All official meetings between the European Commission, the Council of the EU and the European Parliament to discuss the medical device and IVD regulatory texts have stopped ahead of the end of the Luxembourg Presidency of the Council. There is a ...
 
07 July 2015
Maureen Kenny
Regulators face a difficult balancing act in the debate over how to get innovative medicines to ...
 
01 February 2016
Mike Snodin discusses the basis of, and possible answers to, some challenging questions on the law ...
26 January 2016
To be successful in emerging Asian markets, medical device companies need superior product and ...
19 January 2016
Charlotte Weekes and Adrian Chew discuss the complicated business of how supplementary protection ...
 
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