Keyword: U.S. FDA

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

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...

Plant Construction & Process Technology

Interoperability in the Pharma Supply Chain

25.01.2012 - Framework - When asked, most people say that they believe regulations should avoid dictating specific technologies but instead should dictate desired outcomes and let industry...

News

Bisphenol A: FDA To Decide On Chemical Used In Food Packaging

09.12.2011 - The U.S. Food and Drug Administration will decide by March 31 whether to ban a chemical used in water bottles, soup cans and other food and drink packaging that may cause harm to...

Plant Construction & Process Technology

Non-compliance is on the Rise

19.10.2011 - Steady Increase - All who follow industry trends will have noticed an increase in regulatory actions related to non-compliance issues. We can see this in the increased issuance of...

Research / Laboratory

Next-Generation Instrument Simplifies Sample Preparation

- Hamilton Bonaduz is introducing the Microlab 600, the next generation of semi-automated laboratory diluters and dispensers for sample preparation. Based on Hamilton's leading...

News

Biofuel Maker Solazyme Shares Rise in Nasdaq Debut

30.05.2011 - Shares of biofuel maker Solazyme Inc rose 15% in their stock market debut on Friday after the company's IPO raised more than expected. South San Francisco-based Solazyme uses algae...

News

Social Media and Networking in the Life Science Industry

09.05.2011 - Social media and social networking are at the forefront for many industries, and the life sciences industry is no different. George Ng, a partner at Gordon & Rees LLP, highlights...