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Drugs

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Electronic Submissions

 Title and Format  Type  Issue Date
Indexing Structured Product Labeling (PDF - 59 KB) Final 6/2/2008
Part 11, Electronic Records; Electronic Signatures — Scope and Application (PDF - 215 KB)

Final

 9/3/2003
Providing Regulatory Submissions in Electronic Format — ANDAs
Withdrawn FR Notice 10/5/2006 		Final
Withdrawn
FR Notice
 6/2002
Providing Regulatory Submissions in Electronic Format -
Annual Reports for NDAs and ANDAs
Withdrawn FR Notice 10/5/2006 		Draft
Withdrawn
FR Notice		 Posted 8/27/2003
Providing Regulatory Submissions in Electronic Format — Content of Labeling (PDF - 28 KB) Final 4/20/2005
Providing Regulatory Submissions in Electronic Format –Drug Establishment Registration and Drug Listing (PDF - 123 KB) Final 5/28/2009
Providing Regulatory Submissions in Electronic Format -Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications(PDF - 133 KB)
To ensure that you have the most recent versions of the specifications referenced in this document, check the appropriate center's Web page. CBER Topics page. CDER Topics page.		 Final

Revised

06/11/2008
Providing Regulatory Submissions in Electronic Format -General Considerations (PDF - 288 KB)   (Issued, Posted 10/22/2003) Draft 10/2003
Providing Regulatory Submissions in Electronic Format-Postmarketing Individual Case Safety Reports (PDF - 107 KB)
To ensure that you have the most recent versions of the specifications referenced in this document, check the appropriate center's Web page. CBER Topics page. CDER Topics page.		 Draft 6/11/2008
Providing Regulatory Submissions in Electronic Format - Prescription Drug Advertising and Promotional Labeling  (PDF - 28 KB)

Draft

 

 1/2001
Providing Regulatory Submissions in Electronic Format--Receipt Date (PDF - 59 KB)   Draft 6/4/2007
Regulatory Submissions in Electronic Format; General Considerations (PDF - 54 KB)  Final 1/1999
Regulatory Submissions in Electronic Format; New Drug Applications 
Withdrawn FR Notice 10/5/2006		 Final
Withdrawn
FR Notice		 1/1999
SPL Standard for Content of Labeling Technical Qs & As (PDF - 58 KB)   Draft 10/2009
    
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