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ACI FDA Boot Camp

By Donald Zuhn, Kevin Noonan, Chris Singer, Sherri Oslick, and Jason Derry

American Conference Institute (ACI) will be holding the next session of its FDA Boot Camp conference on September 27-28, 2010 in Boston, MA. ACI faculty will help attendees: ? Master the complexities of pharmaceutical iP and the regulatory balance between brand name and generic products; ? Analyze the future of follow-on biologics following recent health care reform legislation; ? Recognize the pivotal role of labeling in the drug and biologics approval process; ? Comprehend the structure of the FDA and the roles of the three major agency centers: CDER, CBER, and CDHR; ? Understand the basics of the approval processes...

Full post as published by Patent Docs on July 24, 2010 (boomark / email).