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: October 2013
Final Guidance on Medical Apps
In July 2011, FDA issued a draft guidance on Medical Apps that set out the agency’s approach to regulate apps – even as thousands of such apps were being developed and downloaded by users. Just over two years later in … Continue reading
Posted in Medical Apps
Comments Off on Final Guidance on Medical Apps
Weekly Roundup – 10-4-13
What’s to round up during a week when there is a government shut-down and most FDA staff are off? Well, not much, but I will go over a little and provide some thoughts about next week. But first, remember a … Continue reading
Posted in Weekly Roundup
Comments Off on Weekly Roundup – 10-4-13
Keeping an Eye on FDA When There is No FDA
It would seem like an obvious challenge to write for a blog called Eye on FDA when in fact, there is a government shutdown. That said, an agency that regulates one-quarter of the U.S. economy does not come to a … Continue reading
Posted in Current Affairs
Comments Off on Keeping an Eye on FDA When There is No FDA