# CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/cmc-postapproval-manufacturing-changes-for-specified-biological-products-to-be-documented-in-annual-reports/79b344db-7419-48ec-a38a-6715baf127b4

> FDA guidance document: CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports. Issue date: December 09, 2021. Get complete insights and analysis.

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## Details

- Title: CMC Postapproval Manufacturing Changes for Specified Biological Products 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: 2021-12-09
- Last Changed: 2021-12-09
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2017-D-2802">FDA-2017-D-2802</a>

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