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: March 2007
No Rest for the Weary
New warnings were issued by the FDA for prescription sleep aids yesterday. The media coverage of the issue focused on the claim by some users of these drugs that they experienced "sleep-driving" – getting dressed and getting in a car … Continue reading
Posted in Risk Management
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This is Your State… This is Your State on Drugs – An Intermittent Series
Each year, the National Conference on State Legislatures puts out annual numbers on what is going on at the state level in terms of healthcare legislation. According to the 2005 and 2006 Prescription Drug State Legislative Reports, there were between … Continue reading
Posted in Proposed Legislation
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A Note on Approvable Letters
An approvable letter was issued this week for Accretropin, Cangene‘s recombinant human growth hormone ("rhGH"). "In its action letter, the FDA requested additional support data regarding manufacturing processes. As fulfilling this requirement does not involve further clinical trials, Cangene anticipates … Continue reading
Posted in Approvable Letters
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Weekly Roundup – 3-9-07
Well, I have been wrong before and I was wrong last week when I said we probably saw our last snowfall here inside the Beltway. We had another dusting mid-week. I will probably be wrong again someday. But while we … Continue reading
Posted in Weekly Roundup
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FDA Congressional Testimony on Importation
While the FDA has not yet posted any of Dr. von Eschenbach’s testimony before Congress, that of Randall W. Lutter, Ph.D., Acting Deputy Commissioner for Policy, Food and Drug Administration has been put up on the FDA Web site. He … Continue reading
Posted in FDA Policy
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