FDA’s framework seeks to clear the path for drug companies to create apps for patients

Under a framework FDA released Monday, biopharma companies could disseminate a wide range of apps and other software without submitting it for premarket review.

The proposed prescription drug use related software (PDURS) framework would treat most software that is not listed on a drug’s label as promotional material. Drug companies would be required to submit screen shots or other information describing what consumers see or hear. FDA does not plan to review or require submission of apps or other software that it regulates as promotional material. ...