Earlier this year, in the case of Edwards Lifesciences AG v Cook Biotech Inc, the High Court of England and Wales (Patents Court) handed down a unique and important decision that determines the...
The US Food and Drug Administration has received numerous industry comments on its proposal, announced earlier this year, to run a voluntary secure supply chain pilot programme aimed at increasing...
The judgment by the European Court of Justice in the Damgaard case provides little operational guidance on how to differentiate unlawful advertising for medicinal products from nonpromotional...
The strict application by the European Court of Justice of the law on generic approvals in the case of Generics (UK) Ltd v The Licensing Authority (acting via the Medicines and Healthcare products...
There is no question that some pharmaceutical companies have an easier time than others in negotiating with regulatory agencies. Knowing how best to approach regulators is essential. The differences...
Disputes during drug development between sponsors and division reviewers at the US Food and Drug Administration sometimes cannot be resolved at the division level. Under the guidance document on...
We would like to clarify a number of points regarding the comments made in the May 2009 issue of RAJ Pharma by Brian Ager, the director general of the European Federation of Pharmaceutical Industries...
The Paediatric Regulation (Regulation (EC) No 1902/2006) was proposed by the European Commission to promote high-quality research into the development of medicines for children and to increase the...
Biosimilar medicines have had something of a rough ride the past few years, and it’s not over yet. Ian Schofield reports. As with “standard” generics before them, efforts have been made to portray...
The highest court in the UK has handed down a final answer to the question of whether an innovator company’s product patent is valid if it claims as its “invention” only a single method for the...
A harmonised approach to transparency by the regulatory authorities in the European Union is essential, and a great deal of progress has been made over the past few decades. However, harmonisation is...
When the European Commission presented the preliminary findings of its ten-month inquiry into the pharmaceutical sector in November 2008 1 , the response of the originator industry and its lawyers...
To much fanfare, the European Commission published its preliminary report on the pharmaceutical sector inquiry on 28 November 1-3 . A two-month consultation period is now under way and the final...
A recent opinion of the European Commission ’s Scientific Committee on Health and Environmental Risks (SCHER) that supports the use of non-human primates (NHPs) in biomedical research is...
The United Kingdom’s Pharmaceutical Price Regulation Scheme, which covers all branded licensed medicinal products sold through the National Health Service , has been renegotiated and the revised...
