September 30, 2010
Today Teva Pharmaceuticals announced the receipt of a Complete Response Letter from the FDA for their Biological Licence Application (BLA) for Neutroval. Neutroval is a treatment to reduce the duration of severe neutropenia and the incidence of febrile neutropenia in … Continue reading →
September 29, 2010
There has never been a shyness on the part of members of Congress from weighing in when it comes to FDA examination of a scientific issue. That is unfortunate. Food Safety News reports (along with The Hill) that eleven U.S. Senators … Continue reading →
Posted in FDA Policy, Food
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September 24, 2010
Autumn clicked into place on the calendar early in the week and we were tempted to breathe a sigh of relief, though that would have been silly. Today the temperature is supposed to top 95 degrees. We shall wait until … Continue reading →
September 22, 2010
During the second day of the Food and Drug Law Institute Conference on Advertising and Promotion (#FDLIAP), I participated on a panel to discuss the First Amendment and the Regulation of Commercial speech. The panel was made up of a … Continue reading →
September 21, 2010
I am at Day 2 of the Food and Drug Law Institute Advertising and Promotion Conference being held in Washington, D.C. (#FDLIAP) Yesterday, there were a couple of presentations made by the Division of Drug Marketing, Advertising, and Communications (DDMAC) … Continue reading →