FDA To Disclose Dates Of Complete Generic Applications

Law360, New York (March 3, 2004, 12:00 AM EST) -- In a move designed to help generic drug makers determine if they qualify for 180-day marketing exclusivity, the U.S. Food and Drug Administration has decided to disclose on its website the date an acceptable generic application was received.

Previously, the FDA simply posted a notice that a "substantially complete" generic application had been received and which drug it would copy, and in what dosages.

"Now we are adding an additional column with the date," said Gregory S. Davis, the FDA's deputy director of the Division of...
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