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The Last Days Of NDAs: Uncertainties Remain Ahead Of 23 March Move From Drugs To Biologics

 
• By Sue Sutter

Exactly how many NDAs ultimately will make the switch, the impact of pending applications on 'Orange Book' listings, and the ramifications for ‘authorized generics’ are areas of focus as the regulatory transition date looms.

A row of yellow rubber ducks with one of the ducks facing in a different direction all the other duck are facing. The focus is on the duck facing in a different direction.
Despite 10 years to prepare for the transition, some questions remain a week before the deadline. • Source: Shutterstock

With just one week to go before some protein products in the US undergo a major regulatory transition 10 years in the making, uncertainties remain as to exactly what products will make the switch, when their patent and exclusivity information will be removed from the “Orange Book,” and the impact on currently marketed “authorized generics” of branded insulin products.

On 23 March, insulin, human growth hormone and certain other types of protein products that traditionally have been regulated as drugs will be “deemed”

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