FDA

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.

Pharmacists and patient groups welcome the new European Union directive on pharmacovigilance.

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.