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06 February 2016

 
05 February 2016

An interim report by French government inspectors has identified three 'major failings' in the conduct of the Phase I trial run by the CRO Biotrial that led to the death of one volunteer and the hospitalization of five others with suspected ...

05 February 2016

Click on the links to access the documents. Country Organization Document Status International AHWP Regulation of Combination Products ? a Review of International Practice Final International AHWP Guidance for Preparation of a Common ...

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 ...

04 February 2016

The US Food and Drug Administration will allow some medical device packaging to continue to carry national drug code (NDC) or national health related item code (NHRIC) numbers until 2021, despite a regulation stating the codes need to be removed ...

05 February 2016

An interim report by French government inspectors has identified three 'major failings' in the conduct of the Phase I trial run by the CRO Biotrial that led to the death of one volunteer and the hospitalization of five others with suspected ...

05 February 2016

Click on the links to access the documents. Country Organization Document Status International AHWP Regulation of Combination Products ? a Review of International Practice Final International AHWP Guidance for Preparation of a Common ...

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 ...

04 February 2016

The US Food and Drug Administration will allow some medical device packaging to continue to carry national drug code (NDC) or national health related item code (NHRIC) numbers until 2021, despite a regulation stating the codes need to be removed ...

05 February 2016

An interim report by French government inspectors has identified three 'major failings' in the conduct of the Phase I trial run by the CRO Biotrial that led to the death of one volunteer and the hospitalization of five others with suspected ...

04 February 2016

The US Food and Drug Administration will allow some medical device packaging to continue to carry national drug code (NDC) or national health related item code (NHRIC) numbers until 2021, despite a regulation stating the codes need to be removed ...

04 February 2016

A new patient-reported outcomes instrument for assessing toxicities in oncology trials ultimately could create an opportunity for comparative tolerability claims across cancer treatments. The Patient-Reported Outcomes version of the Common ...

03 February 2016

The European Medicines Agency is seeking feedback on a revised guideline on developing drugs for treating Alzheimer?s disease, a condition for which the agency has warned there is a lack of medicines innovation. The draft document, which was ...

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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Medicines Australia Appoints Interim CEO Australian pharmaceutical industry association Medicines Australia has appointed Lee Hill as the interim chief executive ...
 
   
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