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Reg updates to challenge manufacturers
While the FDA studies up on nanotechnology and stem cells, assuming its 2011 budget request is approved, the regulator will simultaneously update its drug review processes. The "Advancing Regulatory Science" initiative aims to modernize its product evaluation standards. Report
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Also Noted
> Check out the top 10 biopharma deals of 2009 at FierceBiotech. Report
> Savi, a supply chain solutions provider, has unveiled operations-optimizing software that processes real-time data from auto-ID devices attached to mobile or stationary assets. Release
> Contract manufacturer Catalent now provides potent product handling at its manufacturing and packaging facility in Schorndorf, Germany. Article
> Software giant Oracle has launched Argus Safety Suite 5.1, an integrated safety and risk management platform with functionality spanning clinical development through post-marketing. Release
> Dalton Pharma Services in Toronto has passed a Health Canada audit of its GMP facility, used to make, test and ship sterile products. Release
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Special Report
Top 12 GMP Violations
Sometimes it's process complexity, a lack of training, or carelessly done paperwork that leads FDA inspectors to cite drug companies for violating current good manufacturing practices. But at other times violations appear to be attempts to pull the wool over inspectors' eyes. Here's a list of the top 12 GMP violations from the last year. Report
Report
Distrust slows supply chain
IT investments for supply chain management are most desired in the areas of customer (demand) visibility; integrated risk management, and global connectedness, says an IBM Global Business Services/AMR Research survey. But the fundamental issue is trust, according to Hussain Mooraj at AMR Research. Report
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- Silodosin, indicated for benign prostatic hyperplasia (BPH), has been approved by the European Commission
- FDA Drug Safety Communication: Risk of Progressive Multifocal Leukoencephalopathy (PML) with the use of Tysabri (natalizumab)
- Click Commerce to Web-Enable Western Institutional Review Board Processes
- ClearTrial to Demonstrate Dramatic Gains in Clinical Outsourcing Efficiency Achieved by Biopharmaceutical Companies
