FDA

An alliance between two European leaders gives hope for unison but falls short on solutions.

Until the late 80's, Phase III trials were conducted essentially in North America and/or Europe.

New user fees, health initiatives, and FDA compliance concerns are top issues for 2011.

The management board has a supervisory role with general responsibility for budgetary and planning matters, the appointment of the Executive Director, and the monitoring of the Agency's performance.

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

eC-SSRS can serve as an effective approach to meeting the pending FDA regulations.

Some believe that the medical evidence base is distorted by missing clinical trial data.

The European Medicines Agency responds to concerns over conflict of interest and openness.

PCORI, methods panel to set policies for comparing drugs and medical products and practices.

Routine inspections and regulations can help maintain GCP standards in global trials.

Reform law requires tracking and disclosure of fees to investigators and research consultants.

Waiving inclusion/exclusion criteria affects investigators, subjects, sponsors, and the trial itself.

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.

The European Medicines Agency has redesigned its Web site to improve transparency.

Personalized medicine enters the arena.