# M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/m3r2-nonclinical-safety-studies-for-the-conduct-of-human-clinical-trials-and-marketing-authorization-for-pharmaceuticals/fab84a39-1f07-487f-ae13-2eb2b1884d18

> FDA guidance document: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. Issue date: January 21, 2010. Get complete insights and analysis.

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## Details

- Title: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
- 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: 2010-01-21
- Last Changed: 2020-04-24
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2008-D-0470 ">FDA-2008-D-0470 </a>

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