Monthly Archives: September 2008

NIH YouTube Channel

I have always thought YouTube would be a great way to attract people to clinical trials.  There are a lot of barriers to clinical trial participation – lack of knowledge about how they work, availability and a lack of trust … Continue reading

Posted in New and Social Media | 1 Comment

YouTube Warning Letter

A Warning Letter was posted by CDER’s DDMAC on Friday, September 26 that was sent to Shire Pharmaceuticals regarding a Web promotion and a YouTube video for Adderall XR.  While normally Warning Letters are not featured here except in a … Continue reading

Posted in New and Social Media, Warning Letters | Comments Off

CDC Opens New YouTube Channel on Flu

One of the many potential uses of YouTube is the ability of the medium of videos to address issues of public health.  In relatively short order, any entity can put together a video and post it quite inexpensively and in … Continue reading

Posted in New and Social Media | 1 Comment

Weekly Roundup – 09/26/08

It is a dark and stormy day here at the seat of our nation’s government, which is a term that these days should almost be in quotes given the roiling financial situation and the seemingly unparalleled perfect storm of incompetence … Continue reading

Posted in Weekly Roundup | Comments Off

FDA Requests Cephalon to Enhance Risk Mitigation Strategies Consistent with Company’s Recommendations

This is not exactly under the headline of news – a Complete Response Letter (CRL) was issued to Cephalon on the 15th of September for its supplemental New Drug Application (sNDA) for FENTORA(R) (fentanyl buccal tablet) [C-II] as a treatment … Continue reading

Posted in Complete Response Letters, Risk Management | Comments Off