# Regulatory Considerations for Prescription Drug Use-Related Software – FDA Guidance

Source: https://www.keypedia.com/guidances/guidance-document/regulatory-considerations-for-prescription-drug-use-related-software/b7ecd037-ff00-41f8-a303-6ce98d331140

> FDA guidance document: Regulatory Considerations for Prescription Drug Use-Related Software. Issue date: October 20, 2026. Get complete insights and analysis.

---

## Details

- Title: Regulatory Considerations for Prescription Drug Use-Related Software
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2026-10-20
- Comment Close Date: 2023-12-18
- Last Changed: 2026-10-20
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2023-D-2482">FDA-2023-D-2482</a>

## Related Documents

- [Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers](https://www.keypedia.com/guidances/guidance-document/postapproval-manufacturing-changes-to-biosimilar-and-interchangeable-biosimilar-products-questions-and-answers/f3f2a490-2ac9-47b1-82ca-d3a550511aaf)
- [M15 General Principles for Model-Informed Drug Development](https://www.keypedia.com/guidances/guidance-document/m15-general-principles-for-model-informed-drug-development/14c456d2-a084-426f-a4a8-82cdde35dc33)
- [Q8, Q9, and Q10 Questions and Answers (R5)](https://www.keypedia.com/guidances/guidance-document/q8-q9-and-q10-questions-and-answers-r5/0d8061f0-c7e5-49c2-8e30-7202d91074f1)