Keyword: Generic Drug User Fee Act (GDUFA)

Markets & Companies

Opportunities Through Biotechnology

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

Evolution of a Dynamic Healthcare Market

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

GDUFA’s Impact on the API Industry – an Update

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

Enzymes as a Catalytic All Rounder

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

Pharma in India: Responding to Market Dynamics

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

GDUFA’s Impact on the API Industry

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

Chemical Industry’s Expectations for the U.S. Business Climate in 2013

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

FDA Reform Act Signed into Law

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...