RegulatoryGuideline · final

FDA finalises guidance on software outputs linked to prescription drugs and drug labelling

🇺🇸 FDA · Wed 21 Oct 2026

The agency has issued final guidance on applying its drug labelling authorities to certain software outputs disseminated by or for sponsors, finalising a September 2023 draft.

The US Food and Drug Administration has announced the availability of a final guidance for industry titled "Regulatory Considerations for Prescription Drug Use-Related Software". The document is dated 21 October 2026.

According to the agency's summary, the guidance explains how FDA applies its drug labelling authorities to certain software outputs. These are outputs disseminated by or on behalf of a drug sponsor for use with a prescription drug product.

The scope also covers prescription drug-led drug-device combination products. In both cases, the product must have the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research as its lead centre.

The final text completes the process begun with the draft guidance of the same title, issued on 19 September 2023. The full text of the final guidance was not available for this report, so details of any changes from the draft are not covered here.

What it means for your team

  • Sponsors that provide software alongside prescription drugs should check whether its outputs fall within the scope of FDA's drug labelling authorities.
  • Teams working on drug-led combination products should confirm whether CDER or CBER is the lead centre, as the guidance applies only where one of them leads.
  • Regulatory affairs staff should compare the final guidance with the 2023 draft to identify any changes affecting existing or planned software programmes.

Official guideline text: FDA ↗

Article written by VigiEye from the official source (FDA). AI-assisted; check the source before acting.

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