FDA

The act creates serious concerns about the industry's ability to recruit and retain well-qualified investigators.

A new report from EFGCP and EUCROF suggests changes to geriatric trials.

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

The NICE will possess greater power, scope, and status under the new system.

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

Sponsors, health care providers weigh pros and cons of REMS for bringing risky products to market.

FDA is saying that a study coordinator "generally" performs critical functions, such as subject recruitment.

Inspector General study focuses attention on quality of data and patient safeguards.

European network could bring confusion to health technology assessment and clinical research.

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.