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 2009
More on Enforcement from FDA and Shades of More to Come?
As noted in an earlier posting, FDA gave notice on Thursday that the agency was laying out a new vision for enforcement activities. The effort attracted a good bit of media and the FDA even provided a video on the … Continue reading
Posted in FDA Policy
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White House Opens Up New Web Site on Health Care Reform
In addition to the existing site HealthReform.gov, the Obama Administration has set up a new part of WhiteHouse.Gov called "Reality Check" to address some of the myths surrounding the debate on health care reform. It is good use of a … Continue reading
Posted in Proposed Legislation
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How Transparent is the FDA Transparency Blog?
Last month, I wrote a posting called "When Transparency is Easy -Advisory Committee Transparency" suggesting that the transparency at FDA would be greatly enhanced if there were once again links from the rosters of advisory committee members to their CVs. Such … Continue reading
Posted in FDA Policy
3 Comments
Hamburg Puts All on Notice: Enforcement to Pick Up
FDA Commissioner Margaret Hamburg issued notice yesterday that the FDA is going to be laying down the law. It has been oft-noted here on Eye on FDA that enforcement by the FDA has certainly been lax during the Bush … Continue reading
Posted in FDA Policy
1 Comment
The Other Health Care Reforms – FDA Growing by Leaps and Bounds
When the term "health care reform" is uttered, the mind unfailingly goes to think of the current bills being debated here in Washington to change the way health care is delivered in this country, most notably H.R.3200. But there are … Continue reading
Posted in Proposed Legislation
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