The European Medicines Agency provided draft guidance documents focused on the quality of oral modified release products and transdermal delivery patches last week. The EMA anticipates a response by March 2013. The guidelines for patches are fixed toward developers...
The IMDMC 2012 annual conference will be held on Wednesday October 17, 2012 at the Montage Meeting Facility in Indianapolis, Indiana. Come equipped for a full day of events. The session features FDA’s Steve Silverman, Director, Office of Compliance, and CDRH. Pearl...
A study published in the Journal of the American Medical Informatics Association analyzed whether people were more inclined to develop blood clots in the arms and legs depending on their height and weight. The team of researchers at MetroHealth Medical Center and...
Check out the 2012 IBJ Biofutures article covering our expansion last year to Pearl Pathways using this link. You will need to page through to the article on page 33. Key quotes include: “Our clients shaped the direction of our future growth,” says Diana Caldwell,...
According to an article on Outsourcing-Pharma.com, there is a dire need for strong, clear communication between entities when transferring IRB responsibilities. The article, entitled “Sponsor – CRO communication critical to IRB transfer; FDA,” states that all...
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