FDA

Rapid recruitment, potential cost savings, and investigative sites are just a few of the factors attracting sponsors to the region.

A successful investigative team shares their ideas on improving enrollment in children's research.

New Q&A guidance attempts to clear up any confusion about new Directive rules.

The 2005 guidance reinforces adoption of medical imaging for cancer endpoints.

New EU legislation heralds a difficult funding environment for nonprofit research centers.

A growing number of sponsors and regulators are recognizing that accredited organizations are more likely to be compliant.

EU Council supports pediatric medicines proposal, but adds some changes.

The much anticipated list features initiatives in biomarkers and research productivity.

Online trial registries alone will not succeed at rebuilding public confidence.

Out of the remnants of Yugoslavia, Serbia has reasserted itself on the European pharmaceutical stage.

Biomarkers take center stage in Europe, where their critical role is under examination.

More consultations with sponsors promise to drive drug development, but also impose a growing burden on FDA.

Personal integrity is what we need to insist on as the finality of good clinical practice.

The impact of the EU Clinical Trials Directive on current clinical research practices

A system of checks and examinations that helps ensure the quality of clinical trials.

FDA seeks to reduce clinical research failures and make drug labeling more useful.

When negative results arise, novel analysis packages help speed the decision to move forward or pull the plug on a new drug.

As patents expire, clinical trials will be caught in the middle between copyists and original innovators.

Today's technology makes significant improvements in trial safety systems possible.

Drug safety and R&D issues will play a prominent role in user fee program revisions.

Changes prompt new oversight approaches by FDA and research institutions.

As some EU countries struggle with the Directive's regulatory demands, emerging markets such as China, India, and Russia continue to bolster their clinical research and drug development programs.

GRPs are not another set of guidelines or "additional hurdles" prepared by authorities.

New paper from the European Medicines Agency explores future vaccine guideline.

Political and technical tensions in the EU.