Slowdown in new drugs to market prompts antitrust investigation by EU competition authorities.

Broader access to health care data has potential to alter pre- and postmarketing clinical studies.

Balancing the Three-Legged Stool August 1, 2008 By: Jeffrey J. Stoddard, MD

REMS are new only in name. The basic concept has long been central to drug regulation.

Detailed charter defines the roles of the group and their relationships with other study team members—and it's available inside as a word document that you can download for use.

Global harmonization, regulatory flexibility promise to expand treatments for rare and neglected diseases.

From a new guidance on inspections to a bid to help the EU regain its R&D prowess, the Agency is busy.

In the European Union, regulators are agonizing over more than just clinical trials.

In Vitro to the Rescue June 1, 2008 By: Chris Bode, PhD

Chris Bode, PhD, vice president of corporate development for Absorption Systems, explains the impact of in vitro models relative to the Critical Path Initiative.

Comparative drug analysis aims to address costs and value as candidates eye curbs on drug spending.