FDA To Disclose Dates Of Complete Generic Applications

Law360 (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...
To view the full article, register now.
Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.