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October 12, 2008
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.
IND Ethics Loophole
Circare: Academic Patient Advocate
University of Maryland physicist Adil Shamoo, founder of CIRCARE, says there are gaps in existing law that leave patients exposed.
Shark Repellent
Empirica From Phase Forward
A new name for the safety products from Phase Forward, plus insights into faster responses to safety crises.
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.
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.
This week Mark McClellan, the former head of the FDA, said insurance data and electronic health records (EHRs) should be mined for insights into drug safety. His statement is unusual by itself. In the past, ex-FDA bosses tended to be circumspect. One can only surmise that the Bush administration and… more...
Now that half of the U.S. Congress consists of experts on drug safety, we thought it might be a good time to have a chat with Chan Russell. He’s the founder of Phase Forward’s safety division, Lincoln Technologies. Russell sold the company in August 2005 but stayed aboard as president… more...
Progress on post-marketing commitments must be reported to the FDA annually. Earlier this month, the FDA published the most recent figures as of September, 2006. The FDA is tracking more than 1,600 trials with postmarketing commitments from industry. The figures just track what the FDA has mandated for scientific purposes… more...
A federal judge in New York issued a stern but meaningless order concerning Lilly’s internal documents about the bipolar disorder drug Zyprexa. The judge forced a medical consultant and a lawyer to “return” thousands of sensitive documents to Eli Lilly. The losers in the ruling include David Egilman, a Vermont… more...
There’s another wrinkle in the Ketek story. The Wall Street Journal reports on the Congressional testimony of Ann Marie Cisneros. She’s a former employee of Pharmaceutical Product Development (PPD), a leading contract research organization with $1.26 billion in revenues in 2006. The back story is that Sanofi-Aventis was using PPD… more...
The FDA announced labeling changes to Ketek. Sanofi-Aventis’s antibiotic has long been a controversial drug inside the agency and in the community of activists fighting the industry. Sidney Wolfe’s website had flatly urged consumers not to take the drug. Ketek (telithromycin) was approved in the U.S. in 2004, three years… more...
FDA head Andrew von Eschenbach has proposed a partial adoption of Institute of Medicine recommendations about drug safety. The Duke Clinical Research Institute and Mortara Instrument (a European electrocardiogram firm) have been tapped as assisting the FDA in its safety push. The FDA’s CDER division, it seems, is getting an… more...
Like the aftershocks from an earthquake, the political tremors after Vioxx don’t seem to subside. Yes, Merck’s strategy of swatting the pesky plaintiff lawyer-flies one at a time seems to be paying off. And yes, the FDA’s attempt to bolster its own drug safety efforts can now be pondered by… more...
Relsys International announced six new clients for 2006, the company’s 20th anniversary. The company said Pfizer, Otsuka and Solvay had switched from competing drug safety products. Other wins include Pronova AS, Sciclone Pharmaceuticals, and Avexa. Existing customers as Lilly, Novartis, Allergan, Shire, and Novo-Nordisk, Relsys said, were expanding their use… more...
FDA has released a plan for enhancing drug safety. To pay for it, the agency has proposed a 29 percent rise in spending for a renewal of the Prescription Drug User Fee Act (PDUFA), from $304 million to $393 million. By definition, of course, such fees would be charged to… more...
