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FAQ: OTC Drugs

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

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