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Newsletter - December 1, 2016

FDA to Provide Special Help to Manufacturers with New Technology 

In the last few years, the drug manufacturing technology has been going through steep modernization. Some developments are simpler and logical such as use of single-use systems, while others are more complex such as 3D-printed drugs, continuous manufacturing systems, and robotic manufacturing systems. Manufacturers need additional help from FDA to assure continued compliance. 
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Pharma’s Wish List for President Trump: Flexible Regulation

No one knows what President Trump would do next but we can certainly wish that the new perspective would possibly resolve a few issues that have challenged pharma-FDA relations for the last few years. There have been major disagreements over the rigid interpretation of regulations by FDA. Yesterday, the US Congress passed the 21st Century Cures Act with overwhelming bipartisan support. Read More

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