REACH may cost six times more than previously estimated
Implementing REACH, the European chemical legislation, will require a massive increase in animal testing and may cost six times more than previously estimated. More...
Q&A: changing regulatory expectations in Europe
Barbara Jentges, the Managing Director at PhACT GmbH, a regulatory consulting and training firm in Switzerland, speaks about changing regulatory expectations — with a focus on Europe. More...
Merck's new management and organizational structure
Merck & Co. has outlined a new organizational structure and named top management and senior leaders for the company, effective upon the completion of its merger with Schering-Plough. More...
Have you seen our latest issue?
The September issue of Pharmaceutical Technology Europe features articles on combination drugs, superdisintegrants and embryonic stem cells. More...
FDA issues final guidance on OTC drug labelling
The FDA has issued the final draft of its Guidance for Industry titled "Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers." More...
WITNESS software leads to success for Sanofi
Sanofi aventis has finished implementing Lanner's process simulation software into one of its major UK sites following a successful Phase I implementation in which the company made more than £1 million in inventory cost savings in 6 months. More...
One-shot H1N1 vaccine gets Chinese thumbs up
Now expected to obtain its production license during the next few days, an H1N1 vaccine developed by Sinovac Biotech (China) has passed the experts' evaluation by the Chinese State Food and Drug Administration (SFDA). More...
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