FDA

Personalized medicine enters the arena.

The verdict is awaited on the much criticized and long anticipated European clinical trials directive.

The 12-year data exclusivity period has significant implications in delaying the launch of biosimilars.

More information may be available on drug applications to expand public understanding of FDA policies.

The 12-year data exclusivity period has significant implications in delaying the launch of biosimilars.

New guidelines are being developed in Europe to address questions regarding stem-cell medicines.

The newest report from the European Forum for Good Clinical Practice identifies the widely diverse ethical approval system across Europe.

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.

Drug evaluation criteria could soon include an intrusive health technology assessment.

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.