Linguamatics, the leader in natural language processing (NLP)-based text mining, announced that the Federal Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has licensed its 12E text mining platform as a discovery and decision support...
High throughput (HT) Absorption, Distribution, Metabolism, and Excretion (ADME) screening technology is the current push from Big Pharma to be outsourced through contract research organizations (CROs). Shifting also is the ADME regulatory emphasis; the FDA has...
To make best use of its limited resources, the Institute of Medicine (IOM) concludes that the US Food and Drug Administration (FDA) should direct resources to improve the regulatory systems of developing nations to better ensure the safety of the global pharmaceutical...
The average cost of developing a drug was $1.3 billion as of January 2011. The average first-cycle approval rate for standard new molecular entities (NME) has increased from an average of 30% in 1992 to 38% this year. Priority NMEs have fared better with the FDA,...
