Drug Proprietary Name Selection: Draft Guidance Calls For Simulation Studies

FDA draft guidance on developing proprietary drug names recommends series of steps for sponsors to evaluate a proposed name; safety review includes testing name with healthcare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The agency describes how to design such studies in its draft guidance “Best Practices in Developing Proprietary Names...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from United States

More from North America