FDA has poor oversight in medical device monitoring and post market surveillance

According to a British Medical Journal, article on the effectiveness of post-market surveillance, medical device manufacturers “often fail to properly conduct safety studies” and the Food and Drug Administration (FDA) “provides scant oversight” in post-approval monitoring of these devices. The article is published by Jeanne Lenzer and Shannon Brownlee, called  “Why the FDA can’t protect [...]

FDA launches “Basics” transparency microsite

The FDA unveiled phase 1  of its transparency initiative with the launch of FDA Basics, a microsite aimed at demystifying the agency’s workings for the public. It’s the first of a 3 phase transparency initiative launched FDA as part of the Obama Administration’s broader commitment to openness. Phase 2, will deal with disclosure of sensitive information [...]

Linkedin and Social Media is ruining my people- feeble attempts to fight of Social Media and the Compliance nightmare

There has been a flurry of discussion around social media and its implication in the last few  months , So I thought it would be good to have some of these arguments laid out in one single post. Social Media has entered every business and industry even, inside the US Intelligence Community, who sorted out [...]

FDA Webinar Drug Marketing and Advertising Are You Prepared for the Challenges of Social Media?

Since the FDA cracked down on social media marketing and online advertising, drugmakers have been walking on eggshells. A key FDA meeting is scheduled for Nov. 12-13. Read on … Drug Marketing and Advertising Are You Prepared for the Challenges of Social Media? An FDAnews Webinar Thursday, Nov. 19, 2009 • 11:00 a.m. — 12:30 [...]