The US Food and Drug Administration is to hold a workshop in which it will seek stakeholder feedback on the adoption, implementation and use of unique device identifiers in various health-related electronic data systems 1 . Implementing UDIs in ...
Australia's Therapeutic Goods Administration's "should move away from the conservative approach that has characterised its actions in the past and recognise that it has a duty to collaborate with stakeholders to create a culture in which the ...
The lack of medicines approved specifically for children is in the spotlight again, with a report from the European Medicines Agency saying that off-label prescribing is still widespread in the EU, despite the fact that the practice is associated ...
Spain has transposed into national law European Union Directive 2006/123/EC on free access to services in the internal market 1 . The new ?omnibus law? 2 updates a total of 47 national laws, one of which is the national Law on Guarantees and ...
Ravimiamet, Estonia's drug regulatory agency, has intensified its oversight of television advertisements for medicinal products, after finding that all advertisements televised on three TV channels in June failed to comply fully with the legal ...
Two clauses in the Association of the British Pharmaceutical Industry's new code of practice that will ban the distribution of branded promotional items and require companies to declare certain payments they make to healthcare professionals have ...
The US Senate Judiciary Committee has approved a bipartisan bill to limit pay-for-delay settlements that the bill's supporters say will keep lower-cost generic drugs off the market 1 ,2 . The Preserve Access to Affordable Generic Drugs Act, which ...
The US Food and Drug Administration is proposing to remove a controversial legislative provision that requires unauthorised wholesale distributors of prescription drugs to provide purchasers with a statement describing the product's chain of ...
As of 1 October, the Swedish Medical Products Agency will accept variations for nationally approved medicines only if they are submitted according to the EU variations regulation (Regulation (EC) No 1234/2008) 1 . The variations regulation, which ...
Following extensive consultation with stakeholders, Health Canada has finalised a set of guidelines that reflect the authority?s new policy on reporting postapproval changes to drugs, biologics and radiopharmaceuticals 1 . The guidelines came into ...
