January 18, 2019Safety

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Pondering EHR Access

Relsys: Beyond Clinical Data

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

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Ready for REMS

Relsys On Managing Safety

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

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'Absolutely overwhelming'

FDAAA Update At DIA

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

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New Woodcock Role?

PhRMA Safety Surveillance Pilot

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

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Business As Usual

Wyeth on FDAAA

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

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Database Finds 150K Patients

In Silico Studies By i3 Innovus

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

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

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Shark Repellent

Empirica From Phase Forward

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

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A-List Of Speakers At Harvard

Post-Approval? Or Pre-Apocalypse?

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

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Strategies from Wyeth, Actelion & Pfizer

CTC 2008: Proactive Risk Abatement

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

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Litigation Into Perpetuity?

Drug Safety: A Lawyer’s View

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

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Trasylol, Bayer & Three Mile Island

Drug Safety Story Time

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

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Less Dictionary-Based Pain

Updated Phase Coding Tool

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

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Fringe Movements

Ode To Abigail

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

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

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Three Ticking Clocks

Bayer Halts Trasylol Sales

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

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