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Draft Guidance On Developing Drug Names Calls For Simulation Studies

 
• By Brenda Sandburg and Elizabeth Crawford

FDA’s draft guidance on developing proprietary drug names recommends steps to evaluate a proposed name, including testing names with health care professionals. The draft notes that OTC “brand name extensions have posed problems when the same root proprietary name is used for multiple products.”

FDA recommends that drug sponsors conduct simulation studies with health care professionals and consumers to evaluate the safety of a proposed proprietary name for a drug product.

The agency describes how to design such studies in its draft guidance “Best Practices in Developing Proprietary Names for Drugs.” FDA announced the availability of the document in...

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