Data from physician offices and hospitals is the next frontier in industry’s assessment of drug safety, Relsys asserts. more...

Relsys says the industry is moving beyond simple reports, and toward bigger systems. more...

FDA’s Sandy Kweder painted a portrait of an agency straining to deliver on the many elements of FDAAA. more...

PhRMA hopes to assist FDA in a broader effort to detect safety signals. more...

Joseph Camardo spoke at the Post-Approval Summit at Harvard, and was wicked smart. Even so, what he didn’t say perturbed us. more...

The health outcomes division of the i3 brand discusses trials that are professionally designed and run on the computer. more...

University of Maryland physicist Adil Shamoo, founder of CIRCARE, says there are gaps in existing law that leave patients exposed. more...

A new name for the safety products from Phase Forward, plus insights into faster responses to safety crises. more...

With Mark McClellan and Janet Woodcock on the agenda, the Outcome meeting will be another illuminating event this year. more...

A report from the Clinical Trials Congress about risk. One message: start a regulatory conversation early. And consult your preclinical team. more...

A lawyer says litigation illuminates how the pharmaceutical industry thinks and conducts itself. A few forward-looking statements. more...

Reflections on the power of narrative and the industry’s wobbly reputation. more...

Updating Central Coding for InForm, Phase Forward tries to simplify the management of vital dictionaries like WHO Drug and MedDRA. more...

With the Supreme Court putting a long-simmering case to rest, we take a look at the lessons of the Abigail Alliance. more...

The first class action settlement for Vioxx is good news for Merck but will play out differently for industry. more...

With journal editors in charge of drug safety, the political system has failed the industry and the public. more...