US FDA offers draft guidance on electronic informed consent
The draft guidance comes in the form of a Q&A and offers clinical investigators, IRBs and others a look into how electronic informed consent (eIC) should be done properly.
Archives for March 9, 2015
Update
Icon doubles down on devices with new research group
CRO Icon has launched a new medical device and diagnostics research group following the combination of recently acquired Aptiv Solutions’ expertise with its own experts.
Patheon focuses on solubility with acquisition of Oregon-based CDMO
For the second time in just over a week, CDMO Patheon has made an acquisition, this time for Agere Pharmaceuticals, a privately held CDMO based in Bend, Oregon, that specializes in improving the bioavailability of drugs.
APIs in banned sex supplements sold openly online says regulator
Tests show Viagra and Cialis APIs present in over 100 brands of bogus ‘sexual enhancement’ pill.
Slew of recalls, Form 483 shake Hospira
Quality troubles for Hospira continue as the company announced on Friday recalls of two injections, in addition to the recall of two infusion pumps, as well as a Form 483 for an Indian manufacturing site.
CRO forum elects Quintiles, INC Research execs as chairs
The Association of Clinical Research Organizations (ACRO) held the inaugural meeting of the previously announced CRO Forum, which was established in October to increase interactions between the CRO industry and industry group TransCelerate BioPharma.
Anthrax vaccine stability data delivers contract extension for Glide Technologies
US desire for an alternative to the current multi-shot anthrax vaccine is a boon for delivery systems firm Glide Technologies, which had its contract extended by Pfenex this week.
Wuxi lowers projections for FY 2015 due to CapEx investments, stock takes 10% hit
Aggressive investment in new manufacturing capacity and new initiatives in genomics and cell therapy in 2015 is forcing CRO Wuxi to lower its expectations for 2015, and the lowered projections also seemed to have caused the company’s stock to fall by as...