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: March 2011
No News is No News – DDMAC Fails to Produce Guidance
As many might have guessed, the second target date set by FDA’s DDMAC for the issuance of a Draft Guidance on Social Media and the Internet is about to pass, apparently without any new developments. Slated for the end of … Continue reading
Posted in Uncategorized
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Tracking FDA Progress on Health Care Reform
When the Affordable Patient Care Act (more commonly known as Health Care Reform) became the law of the land, it had several provisions in it that charged the FDA with very particular tasks as part of the implementation of the … Continue reading
Posted in FDA Policy, Uncategorized
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Weekly Roundup – 3/25/11
Congress has been gone this week which has made the local commute quite bearable, though one has to wonder how they could all take off when they haven’t finished a budget for this fiscal year. Spring here is being threatened … Continue reading
Posted in Weekly Roundup
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DDMAC – Unclear Transparency on FDA Social Media Guidance
For many years now, there has been a long wait after a public hearing held in 1996 on some form of guidance from the FDA that would provide communications guidelines for this new medium. Fifteen years have passed and those … Continue reading
Posted in FDA Image, FDA Policy
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Does Japan Tragedy Cause Re-Think on FDA Funding?
The trio of tragedies that hit Japan are now spawning a fourth – the potential for radioactive contamination of food and water. There are now reports that the FDA has banned food imports from four prefectures – those located closest … Continue reading
Posted in FDA Policy, Food, Uncategorized
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