FDA

Modernizing the Common Rule to update research policies could spell important changes.

While order might be useful for smaller firms to do business, it is not useful in helping them to innovate.

Open Facebook walls could bombard companies with AERs.

EU's new rules will be influenced by more than just those primarily responsible for pharmaceuticals.

A meeting in July to discuss changes to the old rules explored the need for compromise across the industry.

Pharmaceutical testing and production overseas spurs call for more reliance on counterparts.

Partnership formation is the new trend in common technical document development.

A newly released report has the pharma industry facing some new rivals.

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.