# Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/changes-to-an-approved-application-for-specified-biotechnology-and-specified-synthetic-biological-products/cb3f7a7e-cd25-442c-b55c-ea551ae637f8

> FDA guidance document: Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products. Issue date: July 01, 1997. Get complete insights and analysis.

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## Details

- Title: Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products
- 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: 1997-07-01
- Last Changed: 2020-04-30
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-1995-D-0101">FDA-1995-D-0101</a>

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