# E19 OPTIMISATION OF SAFETY DATA COLLECTION - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/e19-optimisation-of-safety-data-collection/e2f8a0da-582a-4c4a-946d-b9039d8729bb

> FDA guidance document: E19 OPTIMISATION OF SAFETY DATA COLLECTION. Issue date: June 27, 2019. Get complete insights and analysis.

---

## Details

- Title: E19 OPTIMISATION OF SAFETY DATA COLLECTION
- 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: 2019-06-27
- Comment Close Date: 2019-08-26
- Last Changed: 2020-04-20
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2019-D-1828">FDA-2019-D-1828</a>

## Related Documents

- [Q3E Guideline for Extractables and Leachables](https://www.globalkeysolutions.net/guidances/guidance-document/q3e-guideline-for-extractables-and-leachables/4b0a399e-ea86-4269-bcb2-e0cf8c88b5bd)
- [M11 Clinical Electronic Structured Harmonised Protocol](https://www.globalkeysolutions.net/guidances/guidance-document/m11-clinical-electronic-structured-harmonised-protocol/08512de5-c7ff-456b-b915-b60eff6e9560)
- [M10 BIOANALYTICAL METHOD VALIDATION](https://www.globalkeysolutions.net/guidances/guidance-document/m10-bioanalytical-method-validation/0bcad818-8b44-4227-b811-ea24e68f81cd)
