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Drug Proprietary Name Selection: Draft Guidance Calls For Simulation Studies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FDA draft guidance on developing proprietary drug names recommends series of steps for sponsors to evaluate a proposed name; safety review includes testing name with healthcare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The agency describes how to design such studies in its draft guidance “Best Practices in Developing Proprietary Names...

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More from United States

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Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

More from North America

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

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• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

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