This new paper on AI and machine learning (ML) in drug development includes the use of any software that is regulated as a medical device for the drug development process. Indications are that such a software development project may require deep pockets.
Clinical trial monitoring for FDA-regulated products can be expensive and troublesome, but digital health technologies (DHTs) can make the process less painful and more cost-efficient. However, in order for clinical trial sponsors to enjoy these benefits, proper planning and execution will be necessary, according to a new FDA guidance for clinical trial monitoring.
The FDA has released a framework for the use of digital health technologies (DHTs) in the development of pharmaceuticals and biologics, but the FDA’s Center for Devices and Radiological Health (CDRH) will be intimately involved in this project.
The FDA’s new draft guidance for the use of digital health technologies (DHTs) for remote data acquisition in clinical trials promises to help advance the market for a wide range of products in the digital health space. However, developers of these products should be aware that their products will be subject to a substantial amount of verification and validation work, along with a considerable load of usability studies.
Electronic Quality Management System
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