Combination Products: US FDA Aims For Limited Two-Application Solutions

In announcing guidance stating one application generally is sufficient for a combination product, FDA asks for comments on situations where two would be needed.

medical technology concept,smart doctor hand working with modern laptop computer in modern office with virtual icon diagram

A combination product generally should require only one application for approval, but the US FDA wants to know the situations when two may be necessary.

The agency's draft guidance describes "high-level," basic elements of the potential premarket approval pathways for combination products, one of...

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 Review Pathways

More from Pathways & Standards