An Overview of FDA Requirements for OTC Drugs (Over the Counter Products ) and understanding FDA regulation for OTC drugs
FDA requirements for OTC drugs vary for OTC monograph products and new OTC drugs. Drugs with active ingredients published in the OTC final monograph which can be marketed without prior approval from FDA. However, if you are planing to market OTC drugs with active ingredients which are not part of the OTC monograph you should … Continue reading An Overview of FDA Requirements for OTC Drugs (Over the Counter Products ) and understanding FDA regulation for OTC drugs
