AAP Backs OTC User Fees If They Come With Monograph Reforms

The American Academy of Pediatricians (AAP) says its near decade-long press for FDA to establish safety and efficacy of over-the-counter cough and cold products for children shows a dire need to reform the OTC monograph process and increase agency resources through a user fee program. But the group says development of an OTC user fee program should be linked to reforms that let FDA quickly respond to new safety information on monograph products, address monograph products that lack sufficient efficacy...