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....

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...

Drug Safety: Current overview of FDA postmarket surveillance

How can we better execute postmarket drug surveillance?  A recent study proposes formation of a detailed, publicly available database that could be continually updated and aggregated with new information as new clinical study results are published. how does ivermectin...