FDA

Debate narrows over extent of pre-clinical and clinical testing for follow-on versions of complex biologics.

Potential patients entering any trial need to be informed citizens able to understand and assert their rights.

A potential solution for many, personalized medicine still faces economic, regulatory, and cultural challenges.

CER funding boosts agency informatics initiatives that promise to modernize research and review processes

Europe aism to increase jobs and growth through its "Europe 2020" strategy.

FDA, NIH, industry seek new strategies to support drug development, revive pharma pipeline.

Presidential panel to examine need for tighter rules governing US and foreign clinical trials.

March marked a busy month for the UE with guidance updates and the launch of new medicine research.

The European Union is accepting input regarding changes to the directive until the end of May.

FDA's Sentinel Initiative sets pace for tapping e-health records for product assessment.

Patient participation increased drastically in England in 2010.

This guidance has both raised the stakes and improved the odds of securing label claims based on PROs.

Renewed pandemic fears drawn the sting from criticisms of industry and regulators.

The guidance has driven the industry to take note of the patient-to listen, understand, and document.

Congress readies probes of FDA practices, while FDA seeks transparency and organizational changes.

GCP training will be the main point of discussion at the EFGCP meeting in February.

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.