# Postapproval Changes to Drug Substances Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/postapproval-changes-to-drug-substances-guidance-for-industry/78d470cd-b4c0-45be-b582-1163b9b97017

> FDA guidance document: Postapproval Changes to Drug Substances Guidance for Industry. Issue date: September 11, 2018. Get complete insights and analysis.

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## Details

- Title: Postapproval Changes to Drug Substances Guidance for Industry
- 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: 2018-09-11
- Comment Close Date: 2018-11-09
- Last Changed: 2022-05-25
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2018-D-3151">FDA-2018-D-3151</a>

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