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CDER Permits Some Combo Product Software To Be Submitted As DMFs

 
• By Derrick Gingery

New draft guidance allows electronics or software that will be used across multiple combination products to be submitted as a Type V drug master file, potentially streamlining the assessment process.

Data synchronization of health book between smartwatch and smartphone in male hands
Sponsors have to explain in their applications why the device constituent part should be included in a DMF and not an IND, NDA, ANDA or BLA. • Source: Shutterstock

The US Food and Drug Administration moved to further streamline the combination product approval process by allowing some electronic or software constituent parts to be submitted as drug master files.

When the FDA's Center for Drug Evaluation and Research is leading the assessment of the application, sponsors now can use a Type V drug master file (DMF) to describe electronics...

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