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 European Medicines Agency has issued a draft guideline for companies wanting to develop biosimilar versions of interferon beta for the treatment of multiple sclerosis 1 ,2 . As with all biosimilars, there will be a number of challenges for ...
The US Food and Drug Administration is to host a public workshop on the ethical and regulatory challenges associated with evaluating whether medical countermeasures developed to deal with public health emergencies are safe and effective in the ...
Eduardo Ustaran, Phil Lee and Alison Dennis discuss the European Commission's forthcoming proposals to overhaul data privacy rules and explain how the new regime, if enacted into law, will affect pharmaceutical and medical device ...
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 failed to take the necessary steps to ensure that the labels of marketed antibiotics are kept sufficiently up to date to help clinicians determine the best antibiotic to treat a particular bacterial infection, ...
The European Medicines Agency is seeking feedback on its plan to develop guidance on the use of pharmacogenomics in the pharmacovigilance evaluation of authorised medicines 1 ,2 . The EMA's proposal is outlined in a concept paper that explains that ...
The European Commission is seeking feedback on its plan to extend the scope of the medicines Directive 2003/94/EC on good manufacturing practices so that its provisions will also apply to the manufacturing of active substances 1 ,2 . The proposal ? ...
A revised version of the international Pharmaceutical Inspection Co-operation Scheme ( PIC/S ) came into effect on 1 January, reflecting several recent changes that have been made to the scheme 1 ,2 . The PIC/S scheme, which was formed to allow for ...
The search functionality of Australia's online register of approved devices and drugs has been improved to enable industry, health professionals and consumers to find information on products more easily 1 ,2 . Changes to the Australian Register of ...
The Global Medical Device Nomenclature has been expanded to include a number of new terms for complementary therapy devices for those regulators that now recognise and regulate such products as medical devices 1 . Such terms are specifically in ...
