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Pharmaceutical Technology Europe
Volume 24, Issue 1

News bites

EMA–FDA joint inspections
The FDA and EMA are moving from "confidence-building to reliance upon" each other in a step-up in cooperation on GMP inspections; the latest move following 0completion of pilot projects this summer. The initiative will begin in January 2012.

Read more at: http://www.PharmTech.com/jointgmp

Merck resolves charges
Merck & Co. has agreed to pay $950 million to resolve criminal charges and civil claims related to its promotion and marketing of the painkiller Vioxx. The charges relate to off-label marketing. Under the agreement, Merck will plead guilty to a misdemeanor for its illegal promotional activity and will pay a $321,636,000 criminal fine.

Read more at: http://www.PharmTech.com/vioxx

FDA decides Avastin fate
The breast cancer indication for Avastin has been revoked in the US after the FDA Commissioner concluded that the drug has not been shown to be safe and effective for this use. The drug will, however, remain on the US market as an approved treatment for certain types of colon, lung, kidney and brain cancer.

Read more at: http://www.PharmTech.com/fdaavastin

EC battles superbugs
The EC has unveiled an action plan against antimicrobial resistance, including provisions to promote R&D as well as the possibility of establishing fast-track procedures for marketing authorisations. Among other areas, the EC has highlighted the development of new antimicrobials for treatment as a priority.

Read more at: http://www.PharmTech.com/superbugs


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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
Source: Pharmaceutical Technology Europe,
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