Friday News Briefs
November 09, 2007
I-many, a leading provider of contract management software, has introduced version 5.2 of its I-many Contract Management Suite for Life Sciences. I-many is an advanced business intelligence reporting tool. David Blumberg, executive vice president of fulfillment services for I-many, said: “Factors related to regulatory changes, competition, customer demand, and compliance create the need for more data visibility.…more...
Friday news briefs
November 02, 2007
Top contract research organization Kendle reported a strong quarter but told Wall Street future profits would be lower than expected. Quarterly revenues jumped 33 percent to $100 million. The company lined up $175 million in new business. But net income slipped five percent to $3.8 million. Costs for the merger with Charles River were one issue during…more...
Friday News Briefs
October 12, 2007
In Nevada, a jury ordered Wyeth to pay $135 million to three women who took Premarin and Prempro. The jury said Wyeth acted with malice or fraud. Wyeth has no reserve fund for its hormone replacement therapy (HRT) cases, possibly because it has spent tens of billions of dollars to settle fen-phen litigation. The jury apparently was…more...
CDISC, PointCross, Chiltern
October 10, 2007
According to Gary Buehler, director of the FDA’s Office of Generic Drugs (OGD), pharmaceutical companies should be developing the capabilities to submit common technical document (CTD) applications electronically, or should utilize eCTD applications. Although submitting both new drug applications (NDAs) and abbreviated NDAs in CTD format is recommended by the agency, the FDA will start requiring manufacturers…more...
‘Enough--This Is The Label’
RAPS: CDER’s Kweder, Part II
Reading between the lines of a presentation by Sandra Kweder of FDA-CDER. How industry may have to adapt to an evolving review process at the agency.
eCTD Readiness
Forward-Looking Regulatory Solutions
There is growing interest in software to generate the electronic common technical document (eCTD).
Diary Meeting, Criterium, FCG
Monday News Briefs
Bulletins for July 23.
Cambridge Silo Killers
Rethinking Data Warehouses at Waban
Can your clinical data warehouse combine genotyping data, clinical data and demographic data? And analyze it in a reproducible way? A conversation with Waban.
Clinical Content Management
FCG Partners with Microsoft
Since most people in the industry use Office to create clinical trial documents, Microsoft and FCG say it’s high time there is a secure environment for managing it in a regulated industry. The appeal of MOSS.
Bio-Optronics, Trialstat, Woodcock in NYT
News Briefs
News for June 4th.
Regulatory Systems
Mission3 Manages eCTDs, Projects
The rapidly growing company combines document and project management. “We’re looking at binding those two systems together in an open, web services, modern architecture way,” says founder Dirk Karsten Beth.
