Tag Archives: PRC

3 Risk-Benefit Tips for DTC Websites from FDA Studies


Just recently, the FDA gave us a hint of how they are currently thinking about fair balance and risk information when using websites to advertise.

On April 28, 2011, the FDA proposed and requested comments on three studies to test different ways of presenting benefit and risk information in online direct-to-consumer (DTC) prescription drug websites.  While the comment period is now closed, here’s a summary: Continue reading

5 Short and Sweet Tips for Content Review


If you don’t have the time to sit through a webinar (they are about an hour), here are five short and sweet practical basics I learned while going through the creation and management of a cross-functional promotional review committee (PRC): Continue reading

3 Best Practices Webinars for Content Copy Review


Pharmaceutical and medical device companies are caught up in a new era of FDA/DOJ regulatory oversight and are now racing to develop comprehensive internal procedures for promotional material review and dissemination.  Sure, engaging in social media is the sexy new thing to do, but before your company can engage in social media, you need to have set policies and procedures in place to guide your organization in ALL promotional materials.  Then, you can adjust them to fit the specific needs of new, innovative marketing channels.  Continue reading

70% of Medical Companies Need Social Media Procedures


In December, Deloitte reported that 65% of Life Sciences company professionals use or plan to use social networking.  While the top-line statistics garnered a lot of attention, the following paragraph caught my eye:

Despite the potential risks that could be associated with online social networking, half (50 percent) of surveyed respondents who report they are responsible for managing risk related to online social networks, say their companies do not have a formal risk policy in place and 43 percent do not have procedures for managing adverse events [for social media].Continue reading