FDA to apply light touch to biopharma apps

Concerned that regulatory uncertainty is preventing biopharma companies from developing digital tools that could help patients manage their health, FDA plans to exempt a broad range of apps and other software from premarket review.

In a proposal unveiled Nov. 19, FDA outlined a path that treats software as promotional material if a company doesn’t plan to claim it as necessary for the safe and effective use of a product (see BioCentury Extra, Nov. 19). Such material must be submitted to FDA at the time it is distributed, but in most cases does not require approval or clearance. ...