This US Government Accountability Office’s (GAO) current report (2007) gives a brief history and overview of the 2 FDA branches – Office of New Drugs (OND), and the Office of Drug Safety (ODS) – mandated to oversee postmarketed drug safety. ...
As the old “blockbuster” mentality fades in the wake of relatively weak pipelines, increased emphasis on drug safety, slow sales growth, and the loss of patent protection on older blockbusters, it would appear that the orphan-disease niche (i.e., low...
The dream of tailor-made medication is not a new one, but the prospective cost of such treatments has always been a barrier to growth. Simply put, the return on compounds that only treat small populations cannot justify the investment. With life expectancy...
Although drugs are usually targeted to be selective for a single protein, it is recognized that other proteins may also be affected, a phenomenon called polypharmacology. While off-target interactions can cause potentially harmful side-effects, in some cases, an...
As of 2007, the FDA has the authority to require a Risk Evaluation and Mitigation Strategy (REMS) for certain drugs and biological products, to ensure that the benefits of such products outweighed the risks. Although the FDA mandated risk-management plan applies...
