FDA Calls For Uniform Name For Biogenerics

Law360, New York (October 28, 2004, 12:00 AM EDT) -- The U.S. Food and Drug Administration has ruled out “biogenerics” as a name for generic versions of biotech drugs and will require that any official term for the class of drugs includes the word “protein,” according to a published report.

At a meeting of the Generic Pharmaceutical Association, FDA Acting Commissioner for Operations Janet Woodcock urged the industry to submit its suggestions for an official term. She dismissed “generic biologics” as too broad but said she was “pretty open” to any name that included "protein,” Reuters...
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