Comparative Effectiveness Research to Shape Biotech Studies Authorities are pushing for CE; manufacturers prefer to focus on value.

FDA Launches Transparency Task Force

Comparative Research to Shape Clinical Trials

Compared to What?

Pharma fears comparative effectiveness research will focus on costs and stymie personalized medicine.

Efficient Compliance Without Re-inventing the Wheel

Food and Drug Safety Crises Prompt White House, Congressional Action

How to Shift from Reactive Compliance to Strategic Quality Management

A culture of quality that emphasizes business objectives, risk management, and the informed application of technology can improve compliance.

How can we streamline late-stage clinical development processes to speed regulatory submissions and approvals?

This solution brief explains how SAS solutions streamline and accelerate drug development through better data integration and analysis. The brief explains the features and benefits of the SAS framework and includes a case study documenting the success of a top ?ten pharmaceutical company using the solution.

FDA Releases Guidance on Risk in Ads

You know those loud soundtracks and distracting visuals during the safety information in your TV ads? Critics have been complaining about them, and new draft guidance from FDA is calling them a "no-no."