# CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/cmc-postapproval-manufacturing-changes-to-be-documented-in-annual-reports/67341cfe-8a48-4fc7-9817-6f9ed89768cf

> FDA guidance document: CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports. Issue date: March 05, 2014. Get complete insights and analysis.

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## Details

- Title: CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports
- 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: 2014-03-05
- Last Changed: 2024-02-15
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2010-D-0283">FDA-2010-D-0283</a>

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