Four Major Regulatory Changes to Digital Health Driving New Opportunities for Pharma
Submitted By Anonymous, Created 04/16/2019 - 16:00
- Digital Health Precertification: companies with high degrees of regulatory quality are eligible for shorter reviews and ONC certification
- Multiple Function Devices: The FDA will treat as separate the various functions of a digital health device, making it easier to have full-function products
- Companion Applications: The FDA will allow digital apps intended to supplement prescription drugs to be regulated as labeling and not require approval
- OTC Drug Digital Labeling: OTC drugs drugs may be approved based on evidence that consumers can use digital labeling to select a drug for treatment
Source: PWC
Source URL: https://www.pwc.com/us/acceleration-by-regulation?WT.mc_id=C...