Keyword: Generic Drug User Fee Act (GDUFA)
Markets & Companies
06.06.2014
- Latin America continues to be an area of rising investment for the pharmaceutical industry, with Brazil and Mexico leading the way. Not only is Latin America an attractive target...
Markets & Companies
08.05.2014
- Changing Roles - China's far-reaching presence in the manufacture and supply of active pharmaceutical ingredients (APIs) around the world has long been known. However, with the...
Plant Construction & Process Technology
02.04.2014
- The Price of Doing Business - Following the 2012 implementation of the Generic Drug User Fee Act (GDUFA), an article in CHEManager Europe's July/August 2013 edition about GDUFA's...
Plant Construction & Process Technology
10.09.2013
- The Perfect Storm - More and more chemical and pharmaceutical companies are recognizing the need to make their processes more environmentally sustainable, a trend that is right at...
Plant Construction & Process Technology
09.09.2013
- New Focus - The importance of Indian companies in the global pharmaceutical supply chain is well known and well documented. Large quantities of base chemicals, intermediates...
Plant Construction & Process Technology
06.08.2013
- One-Time Fee - On Oct. 1, 2012, the U. S. Food and Drug Administration (FDA) implemented the long-discussed Generic Drug User Fee Act (GDUFA) , thereby authorizing the agency to...
Chemistry & Life Sciences
29.01.2013
- A Look into the Future - Where is the U.S. economy heading in 2013? Industry leaders predict their companies will navigate uncertainty, including changes in pharmaceutical...
News
20.07.2012
- In a major victory for the American people, President Obama recently signed into law the U.S. Food and Drug Administration's Safety and Innovation Act that will allow the U.S...