Category Archives: Drug Safety

Who Ya Gonna Call?

Today Mashable carried an article entitled “Twitter’s Surprising Reaction to Meningitis Outbreak” that reported that as the meningitis outbreak associated with a contaminated steroid product unfolds, users of Twitter were more often searching for CDC than FDA. The fact that … Continue reading

Posted in Drug Safety, FDA, FDA Image | 1 Comment

Is the Critical Path Initiative in Critical Condition? Is the Advancing Regulatory Science Initiative Replacing the Critical Path?

Does anyone remember the FDA's Critical Path Initiative (CPI)?  Anyone?  Does the FDA even remember the CPI?   The CPI was launched six years ago in 2004 as the "FDA's national strategy for transforming the way that FDA-regulated products are … Continue reading

Posted in Drug Safety, FDA Policy, Science | Comments Off

Change Coming to Pharmacovigilance

Just about every conversation about the use of digital and social media with pharmaceutical companies starts at the same point – NO.  Even if there is a willingness, Med-Reg intimidates and shuts down the effort in most cases, causing the … Continue reading

Posted in Drug Safety | 2 Comments

How Risk Averse Have We Become?

Something I've written about before is the swing of the pendulum from the 1990s to the 2000s in terms of public priorities for the FDA.    What is the balancing act between risk and benefit when it comes to both … Continue reading

Posted in Drug Safety, FDA Policy, Food | 2 Comments

FDA to Post Quarterly Report of Potential Safety Issues

There are few better ways to bury news than to send out a release on Friday afternoon.  The FDA announced this past Friday afternoon that it would begin to post potential safety issues on the Internet.  There are those who … Continue reading

Posted in Drug Safety, FDA Policy | 2 Comments