According to a report published this month in the Archives of Internal Medicine, serious and fatal adverse drug events (ADEs) reported to the FDA’s Adverse Event Reporting System (AERS) have more than doubled in the period 1998–2005. Established in 1998, the AERS receives ADE reports from the FDA and drug manufacturers. Serious ADEs increased by […]

In August, the US Patent and Trademark Office (USPTO) announced new rules for the patenting process, which will take effect on November 1. Under the new rules, patent submissions can not include more than 25 claims, and inventors will only be able to file two new “continuing applications,” which allow inventors to add further claims […]

: In June, DuPont and Environmental Defense (ED) introduced the Nano Risk Framework, a joint effort to improve research on environmental, health and safety issues pertaining to nanotechnology. At its most basic level, the Framework calls for a multistep risk analysis assessment before the use of nanotech products or processes, followed by regular reexaminations of […]

The Cancer Biomarkers Collaborative (CBC), a joint project of the American Association for Cancer Research, the FDA and the National Cancer Institute (NCI), is one of a number of collaborations designed to integrate biomarkers into drug development. The CBC will draft guideline recommendations for the FDA’s Critical Path Initiative in the following areas: collecting biospecimens […]

The Economist Intelligence Unit (EIU) predicts that prices for industrial commodities, measured by the EIU’s Industrial Raw Materials (IRM) index, will rise by an average of 12% this year. These high prices have not affected demand, partially because prices of all commodities have risen, making substitution less likely. An even greater driver of demand is […]