Industry has reservations about possible user fees to support FDA's OTC drug monograph activities, but the agency is fairly adamant that the program needs greater funding, particularly if it moves forward with a potential overhaul of the system to improve its functioning.
"The FDA does want to see changes to the way that the monograph regulation works to make it a lot more efficient and streamlined," said Karen Mahoney, deputy director of FDA's Division of Nonprescription Drug Products, in an interview leading up to the