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The Final FDA Orphan Drug Regulations Released

June 24, 2013

The final FDA orphan drug regulations have just been released and will be effective as of August 12th … but what does this mean for the pharmaceutical industry and patients alike?

Get your questions answered at CBI’s Orphan Drug Innovation Summit!

Michelle L. Butler, Director, Hyman, Phelps & McNamara, P.C.; Author, FDA Law Blog, will discuss details on the ruling and the concerns surrounding the ongoing litigation, including:

•   The difference between the terminology of “orphan subset” and “medically plausible”
•   Eligibility for Orphan Drug Designation
•   The demonstration of “Clinical Superiority” and the “feasibility of issuing a draft guidance document” by the FDA to determine clinical superiority for certain products
•   Real world examples of ongoing litigation that challenges the FDA’s interpretation
•   And much more.

CBI’s Orphan Drug Innovation Summit brings together key industry perspectives and provides thought-provoking sessions surrounding these regulations, including:

•   The Orphan Drug Act — 30 Years Later and Still Going Strong
•   Capture Value from Canada’s First Ever Rare Disease and Orphan Drug Regulatory Framework.

Plus! Are you looking to send a team? Take advantage of exclusive group discounts! To learn more about special rates, please contact Stuart Steller ( at 339-298-2158.

Please Note: The Orphan Druganaut Blog is a Media Partner.

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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