Room For Innovative Switches Could Lurk In Existing FDA Framework

When firms suggest submitting switch NDAs for “something that would be worth engaging on, we’re not going to tell you no,” says FDA nonprescription drug program chief Theresa Michele.

Innovative Rx-to-OTC switches could be considered under FDA’s’ existing regulatory framework, nonprescription drug program chief Theresa Michele says in encouraging firms to make proposals.

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