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...
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....
As of 2007, the FDA has the authority to require a Risk Evaluation and Mitigation Strategy (REMS) for certain drugs and biological products, to ensure that the benefits of such products outweighed the risks. Although the FDA mandated risk-management plan applies...
The U.S. Food and Drug Administration announced (30 Sept 2009) the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies (REMS), which are required for certain drugs or biologics.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...
