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 agency's Center for Drug Evaluation and Research (CDER) is leading the assessment of the application, sponsors now can use a Type V drug master file (DMF) to describe electronics or software "that is planned to be used as a platform," or in multiple CDER-led combination products, the FDA said in new
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