NEWS AND VIEWS FROM THE PHARMACEUTICAL FINE CHEMICAL AND CUSTOM MANUFACTURING SECTOR

Monday 21 June 2010

FDA plans new manufacturing rules

The US FDA is planning to new regulations to tighten up regulations for drugmakers that outsource manufacturing. The FDA said it may require drugmakers to conduct on-site audits of contract manufacturing facilities. Additionally, the agency is considering issuing warning letters to both the contact manufacturer and drugmaker if issues are found.
Wall Street Journal

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