FDA

EU helps ease ambiguity of reporting process with recent published guidance.

Software vendors can help sponsors ensure clinical trial data are accurate, reliable, and authentic.

Why research in Europe has declined since the implementation of the Clinical Trials Directive.

What the agency requires to support the selection of patient reported outcome instruments.

Agency seeks to calm critics by improving subject protection, while also streamlining research oversight.

Payers seek more comparative drug data from sponsors and independent researchers.

European Medicines Agency adopts new approach to drug development process.

This new course aims to provide clinical research physicians with good clinical practice knowledge.

CQA benchmark survey finds companies use a similar method to conduct and report audits.

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.