# GUIDELINE FOR SUBMITTING SUPPORTING DOCUMENTATION IN DRUG APPLICATIONS FOR THE MANUFACTURE OF DRUG PRODUCTS - FDA Guidance Document Source: https://www.globalkeysolutions.net/guidances/guidance-document/guideline-for-submitting-supporting-documentation-in-drug-applications-for-the-manufacture-of-drug-products/711fae04-3dd2-45ec-a781-a15c8bffd0af > FDA guidance document: GUIDELINE FOR SUBMITTING SUPPORTING DOCUMENTATION IN DRUG APPLICATIONS FOR THE MANUFACTURE OF DRUG PRODUCTS. Issue date: February 01, 1987. Get complete insights and analysis. --- ## Details - Title: GUIDELINE FOR SUBMITTING SUPPORTING DOCUMENTATION IN DRUG APPLICATIONS FOR THE MANUFACTURE OF DRUG PRODUCTS - 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: 1987-02-01 - Last Changed: 2019-10-16 - Docket Number: FDA-1985-D-0033 ## Related Documents - [Format and Content of the Clinical and Statistical Sections of an Application](https://www.globalkeysolutions.net/guidances/guidance-document/format-and-content-of-the-clinical-and-statistical-sections-of-an-application/c1b8779c-5190-462a-b56c-64d2fb216db8) - [Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application*: Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/format-and-content-of-the-nonclinical-pharmacologytoxicology-section-of-an-application-guidance-for-industry/4c2b4b0e-2182-43a9-b9b0-c3c92aee26b9) - [Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/submission-documentation-for-sterilization-process-validation-in-applications-for-human-and-veterinary-drug-products-guidance-for-industry/de753251-391e-49ff-a5ac-26a5cad0728a)