'Real Challenge' To Improve OTC Monograph Program Without User Fees – FDA

FDA is weighing the potential benefits of, and drawbacks to, establishing user fees to support its OTC drug monograph program, opening a docket for comments and conducting a June 10 public meeting on the subject. Industry seems far from on board at present, and FDA also acknowledges that there could be downsides to a user fee program in addition to potential benefits for companies and consumers.