Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Section Content Menu
Skip to Common Links
U.S. Food & Drug Administration
A to Z Index
Follow FDA
FDA Voice Blog
Enter Search terms
Most Popular Searches
Home
Food
Drugs
Medical Devices
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Radiation-Emitting Products
Tobacco Products
Drugs
Home
Drugs
Guidance, Compliance & Regulatory Information
Guidances (Drugs)
Section Contents Menu
Guidance, Compliance & Regulatory Information
Guidances (Drugs)
Advertising
Bioequivalence Recommendations for Specific Products
Biopharmaceutics
Biosimilarity
CMC - Microbiology (Chemistry, Manufacturing, and Controls)
Chemistry, Manufacturing, and Controls (CMC)
Clinical / Antimicrobial
Clinical / Medical
Clinical Pharmacology
Combination Products
Concept Papers
Current Good Manufacturing Practices (CGMPs)/Compliance
Drug Safety
Electronic Submissions
FDAAA (Food and Drug Administration Amendments Act)
Generics
Good Review Practices
Industry Letters
International Conference on Harmonisation - Efficacy
International Conference on Harmonisation - Joint Safety/Efficacy (Multidisciplinary)
International Conference on Harmonisation - Quality
International Conference on Harmonisation - Safety
Investigational New Drug Applications
Labeling
Microbiology
Modernization Act
Over-the-Counter
Pharm / Tox
Procedural
Small Entity Compliance Guides
User Fees
-
Electronic Submissions
Below is a sortable listing of Electronic Submissions Guidances
-
Category
Title
Type
Date
Procedural; Electronic Submissions
Electronic Source Documentation in Clinical Investigations
(PDF - 166KB)
Draft Guidance
01/06/11
Electronic Submissions
Compliance Policy on Reporting Drug Sample Distribution Information
(PDF - 92KB)
Draft Guidance
03/29/12
Electronic Submissions
Indexing Structured Product Labeling
(PDF - 59KB)
Final Guidance
06/02/08
Part 11, Electronic Records; Electronic Signatures — Scope and Application
(PDF - 215KB)
Electronic Submissions
Providing Regulatory Submissions in Electronic Format — Content of Labeling
(PDF - 28KB)
Final Guidance
04/20/05
Electronic Submissions
Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing
(PDF - 123KB)
Final Guidance
05/28/09
Electronic Submissions
Providing Regulatory Submissions in Electronic Format -Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
(PDF - 133KB)
Final Guidance
06/11/08
Electronic Submissions
Providing Regulatory Submissions in Electronic Format; General Considerations
(PDF - 54KB)
Final Guidance
01/01/99
Electronic Submissions
Providing Regulatory Submissions in Electronic Format - General Considerations
(PDF - 288KB)
Draft Guidance
10/01/03
Electronic Submissions
Providing Regulatory Submissions in Electronic Format – Postmarketing Individual Case Safety Reports
(PDF - 107KB)
Draft Guidance
06/12/08
Electronic Submissions
Providing Regulatory Submissions in Electronic Format - Prescription Drug Advertising and Promotional Labeling
(PDF - 28KB)
Draft Guidance
01/01/01
Electronic Submissions
Providing Regulatory Submissions in Electronic Format--Receipt Date
(PDF - 59KB)
Draft Guidance
06/04/07
Electronic Submissions
SPL Standard for Content of Labeling Technical Qs & As
(PDF - 58KB)
Draft Guidance
10/01/09
Electronic Submissions
Providing Submissions in Electronic Format -- Standardized Study Data
(PDF - 539KB)
Draft Guidance
02/17/12
-
-
-