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...

FDA Transparency Initiative

As the first phase in a greater transparency initiative, the FDA launched a web-based resource called FDA Basics, which provides basic information about the Agency and how it does it’s work.  In addition, different Centers and Offices in the Agency will host...

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....