One curiosity of the drug safety controversies of the past few years is the low profile of most of the software companies in the niche. One could read the newspaper or your favorite business magazines and imagine that the industry didn’t have people or systems to manage and predict adverse events, that Medwatch paperwork and other forms…more...

A while back, we checked in with someone who makes a living suing the pharmaceutical industry. This week, we worked the other side of the street, chatting with Mark Mansour of Bryan Cave, where he runs the FDA practice group in the firm’s Washington, D.C. office. Mansour has been perplexed, he reports, at the non-approvable letter that…more...

The Food and Drug Administration Amendment Act of 2007 (FDAAA) is vast. And overwhelming. At least one FDA official seems daunted by it, nine months after it became law. Take Sandra Kweder, deputy director of the FDA’s Office of New Drugs. Last month, at the 2008 Drug Information Association (DIA) conference session on how FDAAA will impact…more...

Just as the FDA has received the resources to make a major push into post-marketing drug-safety surveillance under the Food and Drug Administration Amendment Act (FDAAA), the Pharmaceutical Research and Manufacturers of America (PhRMA) says it’s doing the same thing. PhRMA…more...