The FDA has recently made changes to give digital health developers an easier approval process. The new rules give pharmaceutical companies the opportunity to accelerate approvals.
Below are four digital health rule changes that will bring opportunity to pharma, according to a PwC Health Research Institute analysis.
1. Digital health precertification: Pharma companies with high marks on regulatory quality are now eligible for shorter reviews and ONC approval.
2. Companion applications: Digital health apps that are intended to supplement prescription drugs will now be regulated as labeling, meaning they will not require FDA approval.
3. Multiple-function devices: The FDA will treat each function of a digital health device as a separate entity, making it easier to have full-function products.
4. Over the counter drug digital labeling: These drugs can be approved if evidence shows the consumer can use digital labeling to select a drug for treatment.
Date: April 02, 2019