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.
Category Archives: FDA
New Drug Approvals – A Mid-Year Assessment
During the past few years, there has been a renewed focus on facilitating the development of new medicines by providing new mechanisms to streamline the review process and get drugs to patients more quickly. The passage of the 21st Century … Continue reading
Posted in FDA, FDA Policy
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More or Less – A Look at FDA Press Releases at Half Year
What do FDA press releases for the year say about the rate of new approvals for 2016? Periodically I take a look at what FDA has said – and a little bit conversely at what it hasn’t. In April, I … Continue reading
Posted in FDA, FDA Image, FDA Policy
Tagged FDA Press Releases
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Who Ya Gonna Call?
Today Mashable carried an article entitled “Twitter’s Surprising Reaction to Meningitis Outbreak” that reported that as the meningitis outbreak associated with a contaminated steroid product unfolds, users of Twitter were more often searching for CDC than FDA. The fact that … Continue reading
Posted in Drug Safety, FDA, FDA Image
1 Comment
FDA Launches New Look for the Website, Starts a New Blog
Santa’s elves made us some new toys! Either that for the FDA got busy on their own by (1) launching a new look to the Website (thankfully) and (2) starting a new blog called FDA Voice. First things first – … Continue reading
Posted in FDA, FDA Image
2 Comments
FDA Discusses News Reports That the Agency has Withheld Information on Chinese Manufacturers of Heparin from Congress
In February 2008, the FDA announced that heparin, a blood thinning agent, was not going to be manufactured voluntarily by its U.S. manufacturer because of serious adverse events. The adverse events were tied by FDA to a contaminant discovered that … Continue reading
Posted in Current Affairs, FDA, FDA Image
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