CDER Permits Some Combo Product Software To Be Submitted As DMFs
New draft guidance allows electronics or software that will be used across multiple combination products to be submitted as a Type V drug master file, potentially streamlining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.
You may also be interested in...
As more applications include software components, group wants assessors to apply best practices from CDRH to CDER whenever possible.
In announcing guidance stating one application generally is sufficient for a combination product, FDA asks for comments on situations where two would be needed.
But sponsors should sometimes seek advisory comment. Agency explains that most drug-use-related apps will be considered promotional labeling. FDA seeking feedback from a variety of stakeholders on its discussion proposal for regulating prescription-focused software.