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 2008
For Investors
Here is a new addition to the Eye on FDA YouTube channel going under the Investment Vids playlist from Morningstar on Biotech stocks to watch. Morningstar associate director of equity research Debbie Wang offers her take on possible takeout targets:
Posted in Finance
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Weekly Roundup – 08/29/08
Yesterday I turned another year older and was so mesmerized by that fact that I was unable to write a posting – forgive me. Also, I’ve got that "end-of-August-I-don’t-want-to-go-back-to-school" feeling that I’ve never been able to shake in adult life. … Continue reading
Posted in Weekly Roundup
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Abbott Has YouTube Channel
Well, the other day I noted that Lilly had opened up a YouTube account called Lilly Diabetes and a few hours later, the site was closed. I discovered yesterday a new Abbott YouTube site called Abbott1888 – not sure what … Continue reading
Posted in New and Social Media
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FDA Issues New Complete Response Letter
Pursuant to my posting earlier today, by coincidence, Johnson & Johnson announced the receipt of a Complete Response Letter. It is worth noting that they provided no details about the contents of the letter, except to say that there were … Continue reading
Posted in Complete Response Letters
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Approvable Letters/Not Approvable Letters Replaced at CDER by Complete Response Letters – Why it isn’t Potato/Potahto
On August 11, the Center for Drug Evaluation and Research (CDER) put into force a new final rule on the way it respond to New Drug Applications (NDAs) that effectively did away with Approvable Letters and Not Approvable Letters in … Continue reading
Posted in FDA Policy
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