FDA compliance IT setup needs “considerable work”, GAO says
The US FDA IT system for improving oversight of regulatory compliance needs “considerable work”, a GAO report found.
Archives for April 17, 2012
inVentiv responds to Moody’s concerns about integration
inVentiv CEO says PharmaNet and i3 integration ‘essentially complete’ and that – while demand from individual customers can fluctuate - the combination of the two businesses is creating new opportunities.
vivoPharm relocates to Melbourne after buying testing lab RDDT
Australian preclinical CRO vivoPharm has bought toxicology testing firm RMIT Drug Discovery Technologies (RDDT) and will relocated to a new Melbourne HQ.
CSL & Hospira both recalling drugs in separate incidents
CSL Biotherapies and Hospira are both separately recalling drugs due to contamination and syringe overfilling respectively.
INC plans 600-strong dedicated unit to serve Astellas FSP deal
INC Research has formed a FSP deal with Astellas and is building a 600-strong dedicated unit to serve the relationship.
EMA seeks feedback on non-EU API import confirmation letter
The EMA is seeking industry comments on its draft template for written confirmation of API imports from outside Europe.
USP forges closer ties with South Korean FDA
The United States Pharmacopoeia (USP) has agreed to work with the South Korea Food and Drug Administration (KFDA) on the quality of medicines under an MOU signed this week.
News from Centerstone, Bellicum and PhRMA – People on the move
in-PharmaTechnologist presents its weekly round-up of the latest new appointments within the pharmaceutical industry including news from Centerstone, Bellicum and PhRMA.