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: February 2010
Is Congress the New FDA?
Given the dismal track record of the U.S. Senate in the 111th Congress in producing important legislation to improve the lives of Americans, it appears that some of that body's members are looking for new things to do. In the … Continue reading
Posted in FDA Image, Safety and Clinical Trials
3 Comments
Is the Critical Path Initiative in Critical Condition? Is the Advancing Regulatory Science Initiative Replacing the Critical Path?
Does anyone remember the FDA's Critical Path Initiative (CPI)? Anyone? Does the FDA even remember the CPI? The CPI was launched six years ago in 2004 as the "FDA's national strategy for transforming the way that FDA-regulated products are … Continue reading
Posted in Drug Safety, FDA Policy, Science
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Weekly Roundup – 02/19/10
We wind down another week and slowly – ever so slowly – the blizzard of last week begins to disappear, though the traffic effects linger on… and on… and on. And the blizzard didn't stop the government from doing nothing … Continue reading
Posted in Uncategorized
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Become a Fan! Shouldn’t FDA Have a Facebook Page?
The FDA has made a clear effort at promoting transparency and engaging consumers more directly with its Transparency Initiative and in putting out requests to get input from the public, such as the recent Part 15 meetings on social media. … Continue reading
Posted in FDA Image, FDA Policy, New and Social Media
4 Comments
McCain Moves to Give FDA More Authority Over Supplements
On February 4, Senator John McCain introduced S.3002 entitled the Dietary Supplement Safety Act of 2010. If anyone wants to introduce a topic where there should be bipartisan support, this is it. In prior sessions of Congress, Senator Dick Durbin … Continue reading
Posted in DSHEA
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