FDA

Truly integrated risk management requires breaking down silos and strong business leadership from the top.

The agency's 2008 budget fails to keep up with expanding programs, added safety concerns.

EMEA and EC admit to legislation difficulties, and many voice their ideas in an effort to make improvements.

FDA and sponsors implement FDAAA as pressure builds to curb drug prices and tweak the R&D process.

Lack of minority clinical investigators behind dearth of minority subjects in trials.

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Europe's clinical trial community has a lot to say about the EMEA's draft guidance on first studies in man.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

Expanded access to drugs for seniors has increased demand, focusing more attention on medical costs.

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.