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....

Drug Safety Emphasis Did Not Slow FDA Drug Approvals in 2009

New drugs cleared by the Food and Drug Administration (FDA) last year kept pace with 2008 and the number of “black box” warnings decreased, suggesting that the tougher approach to preclinical and clinical drug safety has not slowed approvals. لعب لربح...