# Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations - FDA Guidance Document

Source: 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

> FDA guidance document: Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations. Issue date: February 19, 2016. Get complete insights and analysis.

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## Details

- Title: Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations
- 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: 2016-02-19
- Last Changed: 2020-04-15
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2012-D-0096">FDA-2012-D-0096</a>

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