# Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA: Draft Guidance for Industry and FDA Staff - FDA Guidance Document Source: https://www.globalkeysolutions.net/guidances/guidance-document/submissions-for-postapproval-modifications-to-a-combination-product-approved-under-a-bla-nda-or-pma-draft-guidance-for-industry-and-fda-staff/e6c53755-5cb5-49ce-9d67-07a008f66761 > FDA guidance document: Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA: Draft Guidance for Industry and FDA Staff. Issue date: January 18, 2013. Get complete insights and analysis. --- ## Details - Title: Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA: Draft Guidance for Industry and FDA Staff - Communication Type: Guidance Document - Product Type: devices - Office Name: Office of the Commissioner - Office URL: /offices/office-of-the-commissioner/79483979-9582-427f-ac3d-46c715811424 - Issue Date: 2013-01-18 - Comment Close Date: 2013-04-01 - Last Changed: 2021-05-13 - Docket Number: FDA-2012-D-1240 ## Related Documents - [Cross-Center Master Files: Where to Submit: Draft Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/cross-center-master-files-where-to-submit-draft-guidance-for-industry/6a5cada6-fa5a-48b8-a90f-54033cf59459) - [Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products: Draft Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/essential-drug-delivery-outputs-for-devices-intended-to-deliver-drugs-and-biological-products-draft-guidance-for-industry/4fd9f193-7d92-4a60-9cc8-fb2d65a0d90e) - [Unique Device Identifier Requirements for Combination Products: Draft Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/unique-device-identifier-requirements-for-combination-products-draft-guidance-for-industry/0554749c-ec49-4c7a-a941-ccddf805374a)