FDA

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.

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.

While veteran officials keep the agency running, changes continue at FDA's new drug review and safety oversight offices.

A comprehensive listing of U.S. departments and offices that includes the telephone numbers of directors, commissioners, and advisors.

Three recent initiatives address the reputation of the health care industry in the EU.

Technological advances have lead to an increasingly important role for centralized imaging laboratories.

Implementing ICH E14 to define cardiac safety in new drug development

Janssen Pharmaceutica and Medidata Solutions join forces to institute eSourcing.