About the Author
My name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
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
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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
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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
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