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Article: House Inquiry Into ImClone Could Lead To FDA Changes.
- Article from:
- BIOWORLD Today
- Article date:
- November 4, 2009
CopyrightCOPYRIGHT 2009 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Washington Editor
WASHINGTON - A congressional investigation into ImClone Systems Inc.'s handling of the cancer drug Erbitux eventually could end in a more transparent FDA.
Initiated by the House Energy and Commerce Committee, the investigation started about six months ago when Samuel Waksal, former CEO of New York-based ImClone, said the FDA issued a refuse-to-file letter for the Erbitux rolling biologic license application because it was missing "the train of documentation leading from the raw data to the conclusions."
If the problem were as simple as some missing material, then why not submit the information and be done with it, Rep. Diana ...
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Article: ImClone Appears To Need New Trials; Samuel Waksal ...
BIOWORLD Today;
November 4, 2009 ;
700+ words
... ... closed, ImClone said Samuel Waksal, who has been at ImClone ... director. His brother, Harlan Waksal, previously executive ... the past 18 years," Samuel Waksal said in a prepared ... development of Erbitux," Harlan Waksal said. "I will work ...
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