For the past decade, there has been more and more of a push toward clinical data standardization, and with the Prescription Drug User Fee Act (PDUFA) authorizing the FDA to mandate clinical trial..
In March of this year, an Emerging Technology working group was formed at the FDA/PhUSE Annual Computational Science Symposium. The group was launched with two main areas of focus: metadata..
Last year was record setting for new drug approvals, with 39 new drug and biological products approved in the U.S., the highest number in 16 years. The prediction is for even more approvals in 2013.
Despite their size, small pharmaceutical companies must adhere to the same regulations that govern large ones. Production of statistical computing environments must be validated and compliant; no..