EMA and FDA to start monthly transatlantic drug safety teleconferences
The EMA has confirmed that new monthly drug safety discussions with US counterparts will focus on information exchange rather than policy development.
Archives for February 20, 2014
Glass causes Ben Venue to recall acetylcysteine solution in US
Ben Venue Laboratories, a Boehringer Ingelheim subsidiary that was recently closed after a spate of quality problems, issued a US-wide voluntary recall for its Acetylcysteine Solution 10% at the patient level.
Charles River launches new quality control service for biotech and pharma industry
CRO Charles River Laboratories launched today a new insourcing/outsourcing option for its clients to improve their quality control.
Great Excipact-ations: more excipient firms certified as predicted
Four more drug excipient suppliers have been certified under the newly independent Excipact quality scheme.
Fake US FDA inspector targeting Indian drugmakers in latest scam
Fraudsters who try to extort money by impersonating regulators are an ongoing problem, the US FDA says, after the Gujarat FDCA warns drugmakers about a new scam.
Delays in upgrading Pfizer injectable facility causes shortage
A longer than expected upgrade to one of its injectable plants has caused Pfizer to announce that there is a shortage of methylprednisolone sodium succinate injections.