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2 Become 1: FDA Takes Trip Down Combo Products Premarket Pathway In New Guidance

 
• By Shawn M. Schmitt

The 28 January guidance from the US FDA explains the premarket and submission process for combination products and offers tips to manufacturers as they consider which of the agency’s lead centers should review their product.

2 Become 1.
• Source: Alamy

A new guidance document from the US Food and Drug Administration explains the premarket process for combination products and offers tips to manufacturers as they consider which center should take the lead as their submission wends its way through the agency’s review pathway.

While the 28 January guidance gives suggestions regarding drug-led and biologic-led combo products, this MedtechInsight article focuses solely on

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