FDA extends comment period on generic label updates

FDA extended by 60 days to March 13, 2014, the comment period for a proposed rule that would allow generic drug manufacturers to change the label of a generic independently of the reference brand drug. The agency provided the extension in response to requests for additional time to submit comments. The rule could potentially open the door for generics companies to be held liable for failure to provide adequate warnings (see BioCentury Extra, Nov. 8). ...