BioCentury
ARTICLE | Regulation

FDA to apply light touch to biopharma apps

How FDA wants to make it easier for drug companies to give apps to patients

November 19, 2018 1:51 PM UTC

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. ...