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. panjiva ivermectin import pharmex  A perception exists that the FDA does far more in terms of actual product testing and oversight than it is actually...

Evolving FDA and EMEA Collaborations

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....

Was the REMS meant to regulate prescribers and pharmacists?

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. العاب تجني منها المال  Although the FDA mandated...