# Providing Regulatory Submissions in Electronic Format -- Standardized Study Data - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/providing-regulatory-submissions-in-electronic-format-standardized-study-data/814b3542-7010-4e11-9dfa-23b248ce9cbf

> FDA guidance document: Providing Regulatory Submissions in Electronic Format -- Standardized Study Data. Issue date: June 22, 2021. Get complete insights and analysis.

---

## Details

- Title: Providing Regulatory Submissions in Electronic Format -- Standardized Study Data
- 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: 2021-06-22
- Last Changed: 2022-01-03
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2012-D-0097">FDA-2012-D-0097</a>

## Related Documents

- [Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/providing-regulatory-submissions-in-alternate-electronic-format-guidance-for-industry-guidance-for-industry/c95b38e3-1b57-413c-b3fc-da380f4218da)
- [Providing Regulatory Submissions in Electronic Format: IND Safety Reports Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/providing-regulatory-submissions-in-electronic-format-ind-safety-reports-guidance-for-industry/d8a7e884-2739-4461-b12b-7feef9321c17)
- [Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act](https://www.globalkeysolutions.net/guidances/guidance-document/providing-regulatory-submissions-in-electronic-format-submissions-under-section-745aa-of-the-federal-food-drug-and-cosmetic-act/e05964dd-2751-4636-8630-94e3ed036135)
