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Drug Proprietary Name Selection: Draft Guidance Calls For Simulation Studies

 
• By Brenda Sandburg

FDA draft guidance on developing proprietary drug names recommends series of steps for sponsors to evaluate a proposed name; safety review includes testing name with healthcare professionals.

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

The agency describes how to design such studies in its

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