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: August 2011
Warning Letter and NOV Summary – 2nd Quarter 2011
There has been a lot of commentary about the pick up in enforcement actions by FDA and on the whole, it may be true. But looking at the Division of Drug Advertising, Marketing and Communications (DDMAC), the increase is not … Continue reading
Posted in FDA Policy
2 Comments
Weekly Roundup 8-5-11
It was another long, hot week. The high pressure system over Washington abated somewhat when the Congress actually accomplished something, even though it was something almost no one liked, which apparently saved us from economical disaster, but the market tanked … Continue reading
Posted in Weekly Roundup
Comments Off on Weekly Roundup 8-5-11
TWANK! Pharma Twitter Rankings
This was supposed to happen Monday, but when I hit “Publish” all of the content of the posting disappeared and only the title was sent out. It was not a good way to start the week. I have recovered – … Continue reading
Posted in New and Social Media
4 Comments
A Drug with No Name – Can One Be Approved?
Not long ago, a colleague asked my opinion as to whether or not a drug or biologic could be approved by the FDA even though it still lacked a trade name. Upon thinking about it, I could recall instances where … Continue reading
Posted in FDA Policy
1 Comment