Keyword: Prescription Drug User Fee Act

News

US Gives Merck’s Antitoxin Priority Review

02.02.2016 - The US Food and Drug Administration (FDA) has granted priority review to US drug maker Merck & Co for bezlotoxumab, an antitoxin for preventing the recurrence of Clostridium...

News

US FDA New Drug Approvals Hit 16-Year High in 2012

02.01.2013 - U.S. regulators approved 39 new drugs in 2012, the most in 16 years, suggesting that pharmaceutical makers are poised for growth after losing billions of dollars in recent years 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...