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FDA GUIDANCE FOR INDUSTRY FOR ELECTRONIC SUBMISSIONS

Date Issued	Title	Pages	Doc (.pdf)
7/10/2008	Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (Draft) CDER	14
6/11/2008	Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications  (Final) CDER & CBER To ensure you have the most recent versions of the specifications referenced in this document, check the appropriate center's guidance Web page. For CBER, this Web site is http://www.fda.gov/cber/esub/esub.htm. For CDER, this Web site is http://www.fda.gov/cder/regulatory/ersr/ectd.htm.	20
6/11/2008	Providing Regulatory Submissions in Electronic Format –Postmarketing Individual Case Safety Reports (Final) CDER & CBER To ensure you have the most recent versions of the specifications referenced in this document, check the appropriate center's guidance Web page. For CBER, this Web site is http://www.fda.gov/cber/esub/esub.htm. For CDER, this Web site is http://www.fda.gov/cder/regulatory/ersr/ectd.htm.	11
6/2/2008	Indexing Structured Product Labeling (Final) CDER & CBER	9
5/21/2008	Current Q&As and Change Requests - (Updated) Version 1.14: November 1, 2007 (ICH)	40
6/4/2007	(Draft) Providing Regulatory Submissions in Electronic Format--Receipt Date (Draft) CDER	9
5/10/2007	Computerized Systems Used in Clinical Investigations (OC)	13
9/12/2006	Clarification for Q&A 10 on submitting integrated summaries of safety and effectiveness (ISS/ISE) in the eCTD format	1
12/2005	SPL Standard for Content of Labeling Technical Qs & As (Final) CDER	11
10/18/2005	International Conference on Harmonisation (ICH); Guidance for Industry: Granularity Document Annex to M4: Organization of the CTD (ICH)	13
9/30/2005	International Conference on Harmonisation (ICH); Guidance for Industry: E2B(R) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICH)	26
4/20/2005	Providing Regulatory Submissions in Electronic Format — Content of Labeling (Final) CDER & CBER	8
3/11/2005	International Conference on Harmonisation (ICH) Guidance for Industry: M2: eCTD Specification; Questions & Answers and Change Requests (ICH)	5
12/30/2004	Federal Register: Nonclinical and Clinical Datasets; Notice of Pilot Project	2
12/22/2004	International Conference on Harmonisation (ICH); Guidance for Industry: M-4: CTD -- Efficacy: Questions and Answers (Revision 3)	12
10/22/2003	Providing Regulatory Submissions in Electronic Format - General Considerations (Draft) CDER & CBER	24
9/3/2003	Part 11, Electronic Records; Electronic Signatures — Scope and Application (Final) CDER & CBER	12
8/27/2003	Providing Regulatory Submissions in Electronic Format - Annual Reports for NDAs and ANDAs (Withdrawn 10/5/2006)
4/1/2003	International Conference on Harmonisation (ICH) Guidance for Industry: M2 eCTD: Electronic Common Technial Document Specification	131
6/2/2002	Providing Regulatory Submissions in Electronic Format — ANDAs (Withdrawn 10/5/2006)	.	.
3/26/2002	Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format - Investigational New Drug Applications (INDs)	24
1/2001	Providing Regulatory Submissions in Electronic Format - Prescription Drug Advertising and Promotional Labeling (Draft) CDER & CBER	8
11/22/1999	REVISED Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications [Biologics License Application (BLA), Product License Application (PLA) / Establishment License Application (ELA) and New Drug Application (NDA)]	65
1/1999	Regulatory Submissions in Electronic Format; General Considerations (Final) CDER & CBER	17
1/1999	Regulatory Submissions in Electronic Format; New Drug Applications  (Withdrawn 10/5/2006)	.	.