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...
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...
The U.S. Food and Drug Administration announced (30 Sept 2009) the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies (REMS), which are required for certain drugs or biologics. The Food and Drug Administration Amendments...
