Iqvia describes the new platform as the marriage of eConsent with an authoring system – giving the clinical trial a framework for transparency and transformational change.
The US FDA has modified a 2013 consent decree issued to Ben Venue Laboratories, paving the way for new owners Xellia Pharmaceuticals to resume manufacturing at the dormant Ohio site.
Ranbaxy has temporarily halted all shipments from two API plants currently under a US FDA consent decree, although both the firm and an analyst say a shortage is unlikely.
Ranbaxy has asked the US FDA to withdraw 27 ANDAs for products previously made at Indian manufacturing facilities hit with consent decree earlier this year.
Caraco Pharmaceutical Laboratories has entered into a consent decree with the FDA which details a series of measures that must be fulfilled to allow the company to resume manufacturing.
GlaxoSmithKline has signed a consent decree with the US Food and
Drug Administration to correct manufacturing deficiencies at its
Cidra, Puerto Rico facility, but could be in a position to return
two drugs made at the plant to market...
There is speculation that the problems at GlaxoSmithKline's
manufacturing facility in Puerto Rico may prove to be more costly
for the company than originally thought.