Drug/Software Combos Likely Won't Require Pre-Market Review By US FDA
Executive Summary
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.
You may also be interested in...
Possible Orange Book Revisions Back In Play With US FDA Report To Congress
Agency is setting up an internal working group to assess whether certain patent information should be included or removed from the Orange Book. PhRMA, AAM and others address therapeutic equivalence ratings and listing of device-related and REMS-related patents.
Possible Orange Book Revisions Back In Play With US FDA Report To Congress
Agency is setting up an internal working group to assess whether certain patent information should be included or removed from the Orange Book. PhRMA, AAM and others address therapeutic equivalence ratings and listing of device-related and REMS-related patents.
Real-World Evidence, Digital Health, Insurance Coverage Reforms On Cures 2.0 Agenda
All three areas need work following enactment of the original 21st Century Cures Act, authors Fred Upton and Diana DeGette write in vision statement.