FDA calls for audits of heparin suppliers in draft guidance
The FDA is asking companies to audit heparin suppliers in draft guidance intended to stop a repeat of the 2008 contamination.
Archives for February 14, 2012
Agilent introduces service to cut cGMP lab validation timelines
Agilent has introduced a compliance service to cut the time take to validate and begin production at cGMP laboratories.
News from Patheon, AmerisourceBergen and Premier Research – People on the move
Outsourcing-Pharma presents its weekly round-up of the latest chops and changes within the pharmaceutical jobs market, with news from Patheon, AmerisourceBergen and Premier Research.
Private equity to buy SeraCare
SeraCare Life Sciences has accepted an $82m offer from a US private equity firm six months after it began searching for a buyer.
Trade secret changes critical to regulatory sharing, FDA says
The FDA has said it is critical that trade secret laws are changed to allow it to share manufacturing information with other regulators.
Flat Congress funding will make FDA more reliant on user fees
President Obama’s budget for 2013 projects FDA funding of $2.5bn (€1.9bn), flat year-on-year, but user fees will give it more cash.