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FDA's Drug Center Permits Some Combo Product Software To Be Submitted As DMFs

 
• By Derrick Gingery

New draft guidance from the US agency allows electronics or software that will be used across multiple combination products to be submitted as a Type V drug master file (DMF), 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

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...

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EU Pilots Streamlined Approach To Multinational Combination Product Trials

 
• By Vibha Sharma

EU regulators have approved a strategy to streamline the submission and approval of studies that involve the simultaneous investigation of a medicinal product, an IVD, and/or a medical device. The strategy involves rolling out seven cross-sector projects over the next few years.

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Digital Health Roundup: Synchron Syncs With Apple, Ketryx’s AI Agents, AdvaMed’s AI RoadMap

 
• By Marion Webb, Brian Bossetta, Natasha Barrow, Elizabeth Orr, and Shubham Singh

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Guardant’s Multi-Cancer Detection Test Granted FDA Breakthrough Device Designation

 
• By Natasha Barrow

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GE HealthCare Announces US Launch Of Longer Half-Life PET MPI Agent For Ischemia Detection

 
• By Shubham Singh

GE HealthCare is pursuing a dual-front imaging strategy with its PET MIP agent Flyrcado for detecting artery disease: It lasts longer than current PET scan tracers and allows patients to do treadmill-based stress tests alongside the scan.