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Product safetyFDAUnited StatesImports

Regulatory Considerations for Prescription Drug Use-Related Software; Guidance for Industry; Availability

21 October 2026

In plain English

FDA issued final guidance explaining how its drug labeling authorities apply to prescription drug use-related software outputs disseminated by or for drug sponsors.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
21 October 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Regulatory Considerations for Prescription Drug Use-Related Software." This final 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 product or a prescription drug-led, drug-device combination product that is assigned to the Center for Drug
The full text is at the source

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