Regulatory Submissions in Electronic Format
Guidances and Rules

Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format -- Drug Establishment Registration and Drug Listing - 7/11/2008

Guidance for Industry: Indexing Structured Product Labeling (Revision 1) - 6/17/2008

Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Postmarketing Individual Case Safety Reports - 6/11/2008

Technical specifications associated with this guidance will be provided as stand alone documents. They will be updated periodically independent of the guidance. To ensure that you have the most recent versions of the stand alone documents, check the appropriate center's guidance Web page. For CBER, this Web page is http://www.fda.gov/cber/esub/icsr.htm. For CDER, this Web page is http://www.fda.gov/cder/regulatory/ersr/#Postmarketing.

Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications - 6/11/2008

Guidance for Industry: Computerized Systems Used in Clinical Investigations - 5/10/2007

International Conference on Harmonisation (ICH); Guidance for Industry: E2B(R) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports - 9/30/2005

Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Content of Labeling - 4/20/2005

Draft Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Revision 1) - 1/26/2004

FEDERAL REGISTER Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format; Final Rule - 12/11/2003 - (PDF), (Text)

Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format - General Considerations - 10/22/2003

Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application - 9/3/2003

Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Annual Reports for New Drug Applications and Abbreviated New Drug Applications - 8/27/2003

Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format - Investigational New Drug Applications (INDs) - 3/26/2002

Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format -- Prescription Drug Advertising and Promotional Labeling - 1/31/2001

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)] - 11/12/1999, REVISED 11/22/1999

 
Updated: July 25, 2008