As the first phase in a greater transparency initiative, the FDA launched a web-based resource called FDA Basics, which provides basic information about the Agency and how it does it’s work. In addition, different Centers and Offices in the Agency will host...
Collaboration between the 2 of the world’s premier pharmaceutical regulatory bodies (FDA and EMEA) has increased markedly in the last few years, a process which has come largely in response to the rapid globalization of drug development, manufacturing, and production....
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. In the past...
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...
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...
