Generic Exclusivity? Who Cares! Industry Offers Few Opinions On Potential Changes
This article was originally published in PharmAsia News
U.S. FDA officials still looking for input after transparency issue not widely addressed during GDUFA policy meeting.
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“We might as well talk to an answering machine,” sponsor complains at GDUFA public meeting.
Agency officials indicate feedback is critical as generic drug user fee program enters its third year and applications go on the clock in earnest.
FDA wants to know whether 180-day exclusivity should be revealed up front; question is one of many on ANDA reviews to be considered at September public hearing.