FDA

Along with the titles and phone numbers of personnel, View from Brussels columnist Peter O'Donnell gives an update on the regulatory front in Europe.

Creating sustainable change is the key to fixing this broken process and advancing clinical research.

Expect a raft of new or revised EU guidelines for efficacy testing of pharmaceuticals in '08.

Information systems and lax enforcement criticized as Congress expands trial disclosure requirements.

Europe took a step toward improving the operation of its much-criticised clinical trials directive on October 3-but only a step.

A call to sponsors to rethink the role of ECGs in drug development and the use of central core labs.

The last mile in clinical research is integrating the research site to create a complete information supply chain.

Europe's clinical trial community has a lot to say about the EMEA's draft guidance on first studies in man.

The UK's revised model clinical trial agreements were launched, but have the changes saved time and money?

Getting past consent and ethical issues endemic in underserved populations to ensure quality GCP.

Individual countries hold the key to finding hot spots in growth regions like Central and Eastern Europe.

Guidelines and a checklist ensure those responsible for subject safety and data validity are doing their jobs.

Industry and patient groups embrace new rules but acknowledge concern over initiative's impact across EU.

Additional testing and monitoring requirements promise many changes for pharma R&D.

Until adaptive trials are the norm, industry needs to proceed with care and an iterative approach.

What Canada, the EU, and United States are doing to update their compassionate use regulations.

Journal editors and legislators expand the scope of clinical trial registration and results disclosure.

After a long and winding journey, now the real work begins on the EU Regulation for all those involved.

Who better to educate a wary public about clinical research than the industry's own?

New to the trials scene, many up-and-coming European firms are seeking the expertise of CROs they can trust.

New regulation provides the EU with a solid framework to stimulate R&D for children's medicines.

High-quality programs needed to protect subjects, improve data, harmonize global trials, and manage costs.

New report based on findings from a 2006 research project adds up savings using CDISC standards.