There has been recent discussion around modifying FDA requirements for substantial support of both safety and efficacy in marketing applications. GZP examines the potential fallout on FDA review of drugs, biologics, vaccines, and combination products.
Dr. Evan Siegel was interviewed by Lynn Fosse, Senior Editor, CEOCFO Magazine and the article was published January 7, 2013. You may find this article using the following link.
Drs. Richard Guarino and Evan Siegel will be giving the following course through the Center for Professional Advancement.INDs/NDAs/CTDs
November 29-30, 2012
New Brunswick, NJ
The much-anticipated FDA guidelines on the development and review of biosimilars have been recently released, and biologics developers are scrambling to interpret the resulting risks and opportunities. This blog is the first in a series designed to provide orientation on the guidances, and key suggestions for their practical implementation.
Of interest to many drug developers is the October 19 proposed FDA amendment to the Orphan Drug regulations, to address Agency concerns about Sponsor efforts to artificially subset diseases or conditions to obtain the advantages of orphan status during development and after approval.