Millions of people suffer from occasional heartburn and take an Over-the-Counter (OTC) antacid, H2 blocker, or proton pump inhibitor to relieve the symptoms. But is that always the right thing to do? The FDA wants to make certain such products are properly used and that the public knows use of these OTC products are not without risk.
The Center for Veterinary Medicine has released a revised draft Guidance titled Animal Drug User Fees and Waivers and Reductions, which “describes the types of fees FDA is authorized to collect under ADUFA and how to request waivers and reductions for such fees. It clarifies the criteria for Barrier to Innovation waivers, clarifies the procedures for Small Business waivers,