EMA

A new report from the European Union grades member states on their orphan drug incentives.

Orphan drug development may take a back seat to profit and loss concerns.

Pharma's finger of blame once again points outward, never inward.

The pharma industry won't be the only group rewarded for conducting new pediatric research.

In both oncology and cardiology, new EU rules correct some errors but leave others overlooked.

The EU’s newest draft legislation contains GCP rules that somehow aren’t already law.

Dismay over the level of anti-pharma feeling in the EU is not just "crying wolf."

Editors: David Machin, Simon Day, Sylvan Green (John Wiley & Sons, Ltd, 2004), 428 pages, hardcover, ISBN: 0471987875, £150

To present the new scheme as a time-saver rather than a time-waster, the new guidance points out that the data required is a subset of the data required in any case for the request authorization.

The EU offers up market advantages in exchange for pediatric trials.

In many parts of the globe, intended and actual effects of GCP legislation often differ.

The passing of the EU Directive deadline next month is unlikely to quell the stormy debate over its far-reaching impact.

ACT Editorial Advisory Board members are experts in their field who volunteer to review and comment on manuscripts being considered for publication. EAB members also provide valuable feedback on special programs and projects as well as keep our editorial staff current on the state of the industry. ACT would like to welcome two new members to our Editorial Advisory Board, Scott Grisanti and Uwe Gudat, as well as introduce them to our readers.

With increasing authority, the EMEA is indeed living in interesting times.

Find out what the new EU framework entails; a think tank finds that too much health care energy is going into medicine.

It may be known as "the old continent," but Europe sure as hell comes up with plenty of new rules.

Europe has a new system for pharmacovigilance for human medicines up and running. It's a data-processing network and database management system for dealing with Individual Case Safety Reports (ICSRs) in 18 countries-Iceland, Norway and Lichtenstein, in addition to the 15 European Union member states.

Even as the EU implementation deadline looms, clear clinical trial definitions remain elusive.

European Research Commissioner Philippe Busquin tours Africa to bring attention to the plight of developing nations unable to afford modern medicines.

As information technology becomes more important to clinical trials, the EU is discussing how IT should be included in clinical trials legislation.

The EU has nailed down its strategy for strengthening its clinical trials industry, but it still isn?t clear how it will meet those goals.

The issue of prioritizing clinical trials of pediatric medicines continues to simmer, as plans for planning the possible future legislation develop.

Just like London buses, you wait for one for ages, and then a whole bunch come along at once. That's what's happened with the European Union's guidelines on how the new clinical trials rules should be applied at national level.

Improving the informed consent process and consent forms can not only help subjects better understand clinical research but also reduce the number of invalid consents obtained.

A newly completed study of European ethics committees finds that the bureaucracy of each country determines the way the ethics committees operate.

After committing itself to researching poverty-linked diseases, the EU is working to decide what responsibilities it has to EU-funded research activities in developing nations.

The latest wrinkle in the European Union?s clinical trials rules debate comes from modifications of the draft text at the core of its proposal.

European organizations express their concerns over the implications of the EU guidances issued in response to the 2001 directive.

The World Summit on Sustainable Development may have fizzled, but a promising new long-term clinical trials partnership between the EU, industry, and developing countries is in the works.

Leaders in the European regulatory community examine the implications and merits of the EU?s new clinical trials regulations?and find themselves buried in minor details.