FDA has developed an OTC monograph user fee program based on the PDUFA program. A bill drafted in the House, cited as the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2017, proposes fees for manufacturers of OTC drugs to help fund a portion of FDA’s drug review activities. At a hearing, CDER Director Janet Woodcock testified that FDA has “[not] been able to make timely monograph modifications to account for evolving science and emerging safety issues, or to accommodate product innovation or marketing changes.” OTC review is one of the agency’s largest and most complex regulatory programs, according to Woodcock.
[/membership][membership level=”0,4″][The content continues for paid members only.]
Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership]
