New FDA Transparency Impacts Drug Safety

In the FDA’s effort to make both its decisions and clinical trial data more transparent to the public, Agency decisions have become more available for public debate. ¬†Sophisticated analyses (increasingly by third parties) of publically available data may present...

New Regulatory and Enforcement Emphasis of FDA on Drug Safety

James N. Czaban (FDA Practice Group, Wiley Rein LLP) discusses trending topics of the FDA in regard to drug safety.  A perception exists that the FDA does far more in terms of actual product testing and oversight than it is actually authorized to do, which can result...