# Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA - FDA Guidance Document Source: https://www.globalkeysolutions.net/guidances/guidance-document/comparability-protocols-for-postapproval-changes-to-the-chemistry-manufacturing-and-controls-information-in-an-nda-anda-or-bla/99cef204-366c-4685-b26a-a6a1f744baa3 > FDA guidance document: Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA. Issue date: October 13, 2022. Get complete insights and analysis. --- ## Details - Title: Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA - 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: 2022-10-13 - Last Changed: 2022-10-14 - Docket Number: FDA-2016-D-0973 ## Related Documents - [Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers](https://www.globalkeysolutions.net/guidances/guidance-document/identification-of-manufacturing-establishments-in-applications-submitted-to-cber-and-cder-questions-and-answers/4f5d2866-e1a8-4a27-8196-db286649fbfb) - [Changes to Disposable Manufacturing Materials: Questions and Answers Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/changes-to-disposable-manufacturing-materials-questions-and-answers-guidance-for-industry/2f19a674-0482-4a39-94dc-e1041edbd884) - [CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports](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)