Drug Safety Emphasis Did Not Slow FDA Drug Approvals in 2009

New drugs cleared by the Food and Drug Administration (FDA) last year kept pace with 2008 and the number of “black box” warnings decreased, suggesting that the tougher approach to preclinical and clinical drug safety has not slowed approvals. لعب لربح...

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. how does ivermectin...

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. لعبة...

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...

Personalized Medicine – why the sudden popularity?

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. العاب مقابل المال  With life...