# E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/e19-a-selective-approach-to-safety-data-collection-in-specific-late-stage-pre-approval-or-post-approval-clinical-trials/1c6ec306-023c-4065-80cd-a01e6993d76b

> FDA guidance document: E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials. Issue date: December 05, 2022. Get complete insights and analysis.

---

## Details

- Title: E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials
- Communication Type: Guidance Document
- Product Type: other
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2022-12-05
- Last Changed: 2024-07-29
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2019-D-1828">FDA-2019-D-1828</a>

## Related Documents

- [General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/general-clinical-pharmacology-considerations-for-neonatal-studies-for-drugs-and-biological-products-guidance-for-industry/0c57731e-55bc-4962-a619-54444aa22335)
- [E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/e9r1-statistical-principles-for-clinical-trials-addendum-estimands-and-sensitivity-analysis-in-clinical-trials-guidance-for-industry/e136fe4a-71f3-4725-890a-e85d5d6c6414)
- [Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations](https://www.globalkeysolutions.net/guidances/guidance-document/determining-the-extent-of-safety-data-collection-needed-in-late-stage-premarket-and-postapproval-clinical-investigations/4c1e56b3-7744-4a86-b98b-70593f0edb21)