Day: December 1, 2016

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 … Read more

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. Recently FDA created … Read more