# S6 (R1) Addendum: Preclinical Safety Evaluation of Biotechnology - Derived Pharmaceuticals - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/s6-r1-addendum-preclinical-safety-evaluation-of-biotechnology-derived-pharmaceuticals/de0d3a32-bb96-4225-a321-61404f42a946

> FDA guidance document: S6 (R1) Addendum: Preclinical Safety Evaluation of Biotechnology - Derived Pharmaceuticals. Issue date: May 15, 2012. Get complete insights and analysis.

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## Details

- Title: S6 (R1) Addendum: Preclinical Safety Evaluation of Biotechnology - Derived 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: 2012-05-15
- Last Changed: 2026-06-16

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