Monthly Archives: September 2010

Insight into FDA’s Thinking on a Biosimilar Regulatory Pathway?

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

Posted in Biologics | 2 Comments

The Senate Weighing in on FDA Decisions Says No to GE Salmon

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 | Comments Off

Weekly Roundup – 9-24-10

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

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The First Amendment, Medical Products, and Regulation of Social Media

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

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FDA Must Change Method for Regulating Social Media

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

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