April 2008 – The CenterWatch Monthly : Volume 15, Issue 4, April 2008
FDA Debarment Failures a Wake-Up Call for CROs, Drug Sponsors
After Congressional hearings on the antibiotic Ketek, a Congressional committee issued a scathing report on the FDA’s debarment process. The minority committee charged that debarment proceedings against individuals are inconsistent and haphazard. Staffers uncovered cases where individuals convicted of a felony related to the development or approval of a drug product were not debarred, while other individuals with similar circumstances or convictions were debarred...
CROs: The Promise of Biotech and Beyond
CROs such as Covance, ICON, Kendle, Parexel, PRA, PharmaNet, PPD, Quintiles and others have been working hard to cater to biotech clients for several years. Those efforts should continue to pay off in 2008, which looks to be a good year for biotechs...
Innovative Medicines Initiative Gets Under Way During DIA EuroMeeting
The afternoon session on the first day, March 3, of the DIA Euro-Meeting in Barcelona called “Innovative Medicines Initiative: The EU Commission/EFPIA Public-Private Initiative—Up and Running?” answered affirmatively the question it posed in its title...
Eye On: Osteoporosis
In osteoporosis, the density and quality of bone are reduced, with loss of bone mineral density (BMD) and changes to bone structure causing bones to become more porous, brittle and highly susceptible to fracture. Bones at the hip, spine and wrist are particularly vulnerable to osteoporotic fracture...
- Month in Review
- In the Pipeline
- Opportunities Underway