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: June 2008
FDA Postings on YouTube
Today, the FDA posted a number of videos on YouTube today. It is worth noting that the agency is utilizing YouTube to educate patients. Right now, the FDA has only 61 subscribers and has had a YouTube account since … Continue reading
Posted in New and Social Media
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New Media and Pharmaceutical Public Affairs
This week, I produced a draft of a paper that overviews the use of new and social media in public affairs. I was fascinated to find that not only are several members of Congress now twittering, the Clerk of the … Continue reading
Posted in New and Social Media
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A Guide to the Senate Elections
As we breathe a sigh of relief that the primaries are all finished, and the nominees identified, it is important to take note of the way the character of the election cycle as seen from various perspectives. It is, after … Continue reading
Posted in Legislation
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Approvable Letter Issued to Eurand
Eurand Pharmaceuticals announced last week that the company had received an approvable letter from the FDA for its NDA for EUR-1008 (pancrealipase capsules) for the treatment of exocrine pancreatic insufficiency (EPI). The company did not state the FDA’s reasoning for … Continue reading
Posted in Approvable Letters
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Hurry Up and Wait – Delaying Priority Reviews
Earlier this year the FDA Director of the Office of New Drugs John Jenkins indicated that the agency would have a decreased ability to meet PDUFA dates, saying that the agency was short-staffed. Congress has also been investigating the use … Continue reading
Posted in PDUFA
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