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.
Category Archives: Approvable Letters
FDA Approval Track Record Since Advent of Complete Response Letters
It has been four months since FDA's CDER began issuing Complete Response Letters in place of Approvable or non-approval letters. Looking back to August to get an idea of where we are in terms of the approval of new molecular … Continue reading
Posted in Approvable Letters, FDA Policy
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Cardiome and Astellas Announce Receipt of FDA Approvable Letter for KYNAPID
Today is supposed to mark the day that the FDA quits submitting approvable letters and starts issuing "complete response letters" – but it looks like one flew off the shelf just in the nick of time – at least per … Continue reading
Posted in Approvable Letters
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A Not Approvable Letter That Outlines What is Necessary for Approval
This morning, Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced receipt of a not approvable letter from the FDA for iloperidone, an investigational atypical antipsychotic that was reviewed for the treatment of schizophrenia. It is noteworthy on a few fronts. First, it … Continue reading
Posted in Approvable Letters
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Approvable Letter Update
While it seems that the rate for approvable letters has slowed down over last year, it is nevertheless brisk and I’ve been a bit remiss on keeping up to date. As noted recently, the FDA has acknowledged that it will … Continue reading
Posted in Approvable Letters
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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
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