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

 
• By Derrick Gingery

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The agency's draft guidance describes "high-level," basic elements of the potential premarket approval pathways for combination products, one of...

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