Drug Safety: Current overview of FDA postmarket surveillance

How can we better execute postmarket drug surveillance?  A recent study proposes formation of a detailed, publicly available database that could be continually updated and aggregated with new information as new clinical study results are published.  This essentially...

Drug Safety: FDA’s Postmarket Decision-making Process

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.  ...

Orphan Diseases… a new pharmaceutical strategy?

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...