Drugs

Electronic Submissions

Below is a sortable listing of Electronic Submissions Guidances

CategoryTitleTypeDate
Electronic Submissions Indexing Structured Product Labeling (PDF - 51KB) Final Guidance 06/02/08
Electronic Submissions Providing Regulatory Submissions in Electronic Format — Content of Labeling (PDF - 43KB) Final Guidance 04/20/05
Electronic Submissions Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (PDF - 103KB) Final Guidance 05/28/09
Electronic Submissions Providing Regulatory Submissions in Electronic Format; General Considerations (PDF - 54KB) Final Guidance 01/01/99
Electronic Submissions Providing Submissions in Electronic Format — Postmarketing Safety Reports (PDF - 124KB) Draft Guidance 06/09/14
Electronic Submissions Providing Regulatory Submissions in Electronic Format--Receipt Date (PDF - 218KB) Final Guidance 02/10/14
Electronic Submissions SPL Standard for Content of Labeling Technical Qs & As (PDF - 58KB) Draft Guidance 10/01/09
Electronic Submissions Providing Regulatory Submissions in Electronic Format -- Standardized Study Data (PDF - 132KB) Final Guidance 12/17/14
Electronic Submissions Guidance for Industry: Providing Submissions in Electronic Format -- Summary Level Clinical Site Data for CDER (PDF - 112KB) Draft Guidance 12/18/12
Electronic Submissions Specifications for Preparing and Submitting Summary Level Clinical Site Data for CDER’s Inspection Planning (PDF - 157KB) Draft Guidance 12/18/12
Electronic Submissions Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications  (PDF - 111KB) Final Guidance 05/05/15
Electronic Submissions Providing Submissions in Electronic Format – Postmarket Non-Expedited ICSRs Technical Questions and Answers (PDF - 104KB) Final Guidance 07/24/13
Electronic Submissions Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (PDF - 81KB) Final Guidance 12/17/14
Electronic Submissions Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act (PDF - 114KB) Draft Guidance 07/10/14
Electronic Submissions Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs (PDF - 252KB) Draft Guidance 04/21/15
Part 11, Electronic Records; Electronic Signatures -- Scope and Application Part 11, Electronic Records; Electronic Signatures — Scope and Application 08/01/03

Page Last Updated: 07/30/2015
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