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: April 2006
Blink!
There are many fans of Malcolm Gladwell, author of The Tipping Point and Blink in the public relations industry. Thought you might want to know that he has begun a blog. Click here if you want to catch it….
Posted in Miscellaney, Useful Resources
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Who Killed the Talk Papers?
As I often like to do on Fridays, I’m going to have a post-lite for the blog. I love a good mystery. Remember Talk Papers? They were issued by the FDA when the agency wanted to emphasize an aspect of … Continue reading
Posted in FDA Policy, Miscellaney
1 Comment
At Home HIV Testing – Risks and Benefits
Take a cotton swab. Wash it around the inside of your mouth. Put it in a container. One line means no, two lines means yes. But it doesn’t tell whether or not you are pregnant, it tells you if you … Continue reading
Posted in Risk Management
2 Comments
What Will the Next PDUFA Look Like?
There is an interesting conundrum developing. PDUFA – the legislation that allows for the collection of fees from the pharmaceutical industry to be applied to the FDA budget – is up for debate and reauthorization in 2007. The elections will … Continue reading
Posted in PDUFA, Pharma Industry Image
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Warning About Warnings!
As I mentioned in an earlier posting on February 24, the FDA has dramatically increased the issuance of MedWatch Alerts. Now the Baltimore Sun reports on the issue, which touches upon another matter discussed here – the relevance of FDA … Continue reading
Posted in FDA Policy, Regulatory Communications, Risk Management
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