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Newly released FDA draft guidelines for biosimilar drugs to be discussed at conference
Date:3/1/2012

Mueller-Berghaus, MD, Paul-Ehrlich-Institut; Beatriz Silva-Lima, PharmD, PhD, University of Lisbon; Chris Holloway, PhD, ERA Consulting Group; and Andrew D. Zelenetz, MD, PhD, Memorial Sloan-Kettering Cancer Center.

An international audience of basic researchers, policy makers, and regulatory and public health experts from academia, industry, government, and NGOs will participate in the conversation about the changing regulatory landscape for biological and non-biological complex drugs. The open format of the meeting, including multiple question and answer periods and a working lunch brainstorming session culminating in a full-meeting discussion, will foster dialogue between disparate groups that may aid in defining and determining the criteria for follow-on complex drugs and help move U.S. policy forward.
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Contact: Melinda Miller
mmiller@nyas.org
New York Academy of Sciences
Source:Eurekalert

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