|
|
Article: A new OGD taking shape.(Focus)
- Article from:
- Chain Drug Review
- Article date:
- March 16, 2009
CopyrightCOPYRIGHT 2009 Racher Press, Inc. 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)
|
NAPLES, Fla. -- The possibility of dealing with genetic versions of biotechnology drugs would add to an already crowded plate at the Food and Drug Administration.
But at the FDA's office of generic drugs (OGD), several strategic initiatives have been launched as it undergoes an historic evolution, according to office director Gary Buehler. He outlined the challenges that the OGD and the industry jointly face in a presentation at the annual meeting of the Genetic Pharmaceutical Association (GPhA).
In a frank assessment of the OGD's accomplishments, Buehler conceded that 2008 "wasn't one of its greatest years."
The unit granted 474 full approvals ...