FDA

Employing a three-component risk exclusion model in the assessment of investigational drugs.

FDA eyes risk approaches to site inspections to use resources more efficiently.

The questions and uncertainties that surround electronic patient reported outcomes in Europe.

Second World Conference on Research Integrity will establish global guidelines for promoting integrity in clinical research.

Pharma will pay new fees and rebates but gain drug utilization and safeguards to innovation.

FDA Commissioner Hamburg seeks resources to build agency scientific expertise & new research methods.

Help desk centers offer sponsors the chance to mine valuable PV data.

A look at the directive's flaws and the differing views across Europe about how to fix it.

FDA is modernizing systems to better access data on drug effects, utilization, and safety.

To successfully bring a drug to market and keep it there requires the skills of regulatory scientists.

New commissioner seeks to expand FDA's capabilities to bring safe and effective drugs to patients.

Through new pediatric networks, the EU hopes to improve clinical research in children.

Attention turns to its ederly population and their lack of participation in clinical research.

EMEA responds to more medicines, increase in complex procedures, and plethora of committees.

Globalization and reform initiatives will take part in shaping biomedical research and clinical studies.

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

The latest version of the glossary, providing hundreds of definitions for key terminology related to clinical research.

Find out the latest on industry organizations and what they offer as membership benefits.

A listing of organizations, colleges, and universities that offer courses specific to advancing the education of clinical research professionals.