# Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/mixing-diluting-or-repackaging-biological-products-outside-the-scope-of-an-approved-biologics-license-application-guidance-for-industry/10a78d19-deab-4319-a7fe-ebc2b6b0bb1e

> FDA guidance document: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application:  Guidance for Industry. Issue date: January 18, 2018. Get complete insights and analysis.

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## Details

- Title: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application:  Guidance for Industry
- 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: 2018-01-18
- Comment Close Date: 2017-03-13
- Last Changed: 2019-06-05

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