2023-20241: Regulatory Considerations for Prescription Drug Use-Related Software; Draft Guidance for Industry; Availability
Public comment closed .
Get alerted when the next rule lands
New rules open for comment on their own schedule. Pick how you want to hear about them — we email you when one appears.
Publishing to members? Embed a live rule tracker on your own site — the proposed rules in your area and the comment deadlines closing on them, updating themselves. Free, one line of HTML.
Create a free account & build one →Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Regulatory Considerations for Prescription Drug Use-Related Software." This draft guidance describes FDA's application of its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug or a prescription drug- led, drug-device combination product, which is assigned to the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research as the lead center.
The agency’s own summary, as published.
Don't miss the comment window
One Click Politics alerts you on every deadline, hearing, and rule change.
See all rules with comments due soon →