Market Insight: F-D-triple-A steps out to a mixed reception
This article was originally published in Scrip
Executive Summary
The passage of the Food and Drug Administration Amendments Act (FDAAA) in September 2007 was a major milestone for drug safety efforts in the US. While the extensive new legislation gives the US FDAmore resources, authority and regulatory tools to ensure drug safety, the most important point of the Act may be its mandate that the FDA shift its safety paradigm.