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

Source: https://www.globalkeysolutions.net/guidances/guidance-document/regulatory-considerations-for-prescription-drug-use-related-software/91768cc9-a953-4b59-9da8-4726750c15e7

> FDA guidance document: Regulatory Considerations for Prescription Drug Use-Related Software. Issue date: September 19, 2023. 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: 2023-09-19
- Comment Close Date: 2023-12-18
- Last Changed: 2023-09-18
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2023-D-2482">FDA-2023-D-2482</a>

## Related Documents

- [Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products:  Nonclinical Information](https://www.globalkeysolutions.net/guidances/guidance-document/generally-accepted-scientific-knowledge-in-applications-for-drug-and-biological-products-nonclinical-information/80a1d387-00c7-42b3-90ef-982941cdff8b)
- [Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products](https://www.globalkeysolutions.net/guidances/guidance-document/real-world-evidence-considerations-regarding-non-interventional-studies-for-drug-and-biological-products/48325e39-b445-4a53-8cc0-7483dcf3e352)
- [Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products](https://www.globalkeysolutions.net/guidances/guidance-document/considerations-for-the-design-and-conduct-of-externally-controlled-trials-for-drug-and-biological-products/9dafe0c9-19d4-48c0-a1ca-6b2a04a813ed)