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EnviroTech :: Regulatory :: Regulatory: Legal

EFCG at CPhI: FDA did well to implement GDUFA but disappoints with FMD

1:41 PM MDT | October 9, 2012 | Deepti Ramesh in Madrid

The US FDA did a good job of implementing the Generic Drug User Fee Act (GDUFA), but has disappointed as far as the falsified medicines directive (FMD) of the European Union (EU) is concerned, Guy Villax, CEO of API maker Hovione (Loures, Portugal), and a board member of the European Fine Chemicals Group (EFCG) said at a press conference today at the CPhI trade fair at Madrid. The GDUFA became effective on 1 October 2012. The GDUFA will help increase inspections of US and overseas manufacturers of APIs and finished pharmaceuticals. The global generic...

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