“Today, the U.S. Food and Drug Administration issued a Federal Register Notice “Prescription Drug-Use- Related Software” to announce the establishment of a docket to seek early input from the public on the agency’s proposed framework for prescription drug-use-related software. For the purposes of this framework, prescription drug-use-related software refers to software disseminated by or on behalf of a sponsor that accompanies one or more of the sponsor’s prescription drugs or biologics.”
“The proposed framework is designed to take a risk-based approach to prescription-drug-use-related software. Under this approach, it is anticipated that in most cases, such software would not require review by the FDA prior to dissemination. Generally, the output of such software products…” Read the full press release here.
Source: FDA Brief: FDA takes steps to advance a new framework to promote development of digital tools that can inform the safe and effective use of prescription drugs – November 19, 2018. fda.gov.
