January 31, 2007
Yesterday the FDA announced yet another new initiative on drug safety. This is apparently in addition to the pre-existing Drug Safety Initiative. It is an action taken in response to the Institute of Medicine (IOM) report – The Future of … Continue reading →
January 29, 2007
Last week, a report was issued by the Tufts Center for Drug Development that showed that while the European Medicines Agency (EMEA) – the European Union’s FDA equivalent – had met its performance goals, it was nevertheless lagging behind the … Continue reading →
January 26, 2007
Already the first month of the new year draws to a close. We’ve heard about the State of the Union, such that it is. The days, thankfully, grow longer. And at the FDA, there have been another huge batch of … Continue reading →
January 24, 2007
Following a rash of approvable letters at the end of 2006 for a number of products, Wyeth Pharmaceuticals announced that it has received an FDA approvable letter on January 22 for Pristiq (TM) – desvenlafaxine succinate – a serotonin-norepinephrine reuptake … Continue reading →
A total of seven companies received Warning Letters during the last quarter, meaning that one-third of the year’s letters came in the final three months of the year. What we saw is a mix of large and small companies, with … Continue reading →