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FDA Proposes Orphan Drug Amendment

12/14/2011 / by Dr. Evan Siegel   Of interest to many drug developers is the October 19 proposed FDA amendment to the Orphan Drug regulations, to address Agency concerns about ...

Biosimilars: A Summary

4/4/2012 / by Dr. Evan Siegel   The much-anticipated FDA guidelines on the development and review of biosimilars have been recently released, and biologics developers are scrambling to interpret the ...

CEOCFO Magazine Interviews Dr. Evan Siegel

1/10/2013 / by Dr. Evan Siegel   Dr. Evan Siegel was interviewed by Lynn Fosse, Senior Editor, CEOCFO Magazine and the article was published January 7, 2013. You may find ...

FDA Approval Requirements Changing?

3/14/2017 / by Dr. Evan Siegel   There has been recent discussion around modifying FDA requirements for substantial support of both safety and efficacy in marketing applications. GZP examines the potential ...

Why Changes MUST Go Through Congress

4/6/2017 / by Dr. Evan Siegel     The Food, Drug and Cosmetic Act and Public Health Services Act; Must be Changed through new Law in Congress Last week, we identified a ...

FDA Morale in the New Era of Deregulation

5/4/2017 / by Dr. Evan Siegel     Effects on FDA Morale and the Potential for en masse Resignations of that Agency’s Reviewers In a previous blog we identified several critical processes ...