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                Electronic Regulatory Submission and Review

Electronic Regulatory Submission and Review

                        eCTD Resources
          CDER Data Standards Program
          Data Standards in the Drug Lifecycle
          Electronic Common Technical Document (eCTD)
          Electronic Regulatory Submissions and Review Helpful Links
          Electronic Submissions Presentations
          Study Data for Submission to CDER


                        Data Standards Manual (monographs) Home
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          Electronic Regulatory Submission and Review
          eCTD Important NoticesElectronic Regulatory Submission and Review eCTD Important Notices
  
  	
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    Print**Notice 8/30/2021**FDA FR Notice on high severity eCTD validations 1551&1553

**Notice 8/25/2021**FDA FR Notice on high severity eCTD validations 1306&1323

**Notice 6/23/2021**FDA eCTD v4.0 Validation and CTOC Posted

**Notice 3/09/2021**FDA announces effective date for study data information

**Notice 1/18/2021**FDA eCTD v4.0 Updates

**Notice 11/9/2020**FDA announces end of support for US Regional DTD v2.01 on March 1, 2022

**Notice 7/27/2020**eCTD Submission Type of REMS Supplement is now available

**Notice 6/21/2019**Promotional Labeling and Advertising Materials Guidance

**Notice 1/30/2019
FDA Extends Compliance Date for Submitting DMF Type lll in eCTD format**

The FDA extended the compliance date for submitting DMF Type lll in eCTD format to May 5, 2020. See the FDA guidance document for additional information on the compliance date and FDA’s Drug Master File page for additional information on DMFs.

**Notice 11/30/2018**

FDA plans to accept eCTD sequences with an eCTD submission type of “REMS Supplement” in the future. Implementation date is TBD. See submission-type.xml and M1 Specifications (located in the eCTD Submission Standards) for details.

**Notice 6/1/2018
Please be advised that the FDA’s eCTD Access Data Website will update ciphers and SSL protocols in Production on September 1, 2018**

Please make sure your system used to connect with the FDA’s eCTD Access Data website can connect with compatible secure ciphers and SSL protocols listed below.
SSL Protocols / Cipher Suites
TLS 1.1 or higher

Example links to eCTD Access Data Website:http://www.accessdata.fda.gov/static/eCTD/us-regional-v3-3.dtdhttp://www.accessdata.fda.gov/static/eCTD/us-regional.xsl

**What action do you need to take?**
If you want to continue to access the eCTD Access Data website, you need to ensure your browser(s)/Servers have TLS 1.1 or higher enabled. If your browser or Servers do not have TLS 1.1 or higher enabled after FDA makes this change, then you will NOT be able to access these eCTD websites.

Backend servers that communicate with the eCTD Access Data Website links should also be communicating using TLS 1.1 or higher. Please contact your IT System Administrators or Technology Support personnel for appropriate methods to enable/upgrade your servers.

**Notice 4/24/2018**
FDA Extends Compliance Date for Submitting DMF Type lll in eCTD format

The FDA extended the compliance date for submitting DMF Type lll in eCTD format to May 5, 2019. See the FDA guidance document for additional information on the compliance date and FDA’s Drug Master File page for additional information on DMFs

**Important Notice 5/18/2016
Third Acknowledgement for Successful eCTD Submissions**

Beginning May 31, 2016, CDER will begin issuing an acknowledgement to FDA Electronic Submissions Gateway (ESG) users when their NDA, ANDA, BLA, IND, or DMF submission has successfully completed validation and processing and is available to the assigned review division. This acknowledgement is in addition to the ESG Message Delivery Notification acknowledgement (first acknowledgement) and the Official Center acknowledgement (second acknowledgement) and is referred to as the “third acknowledgement.”

                                                                                  Content current as of:
      04/29/2022
              
              
Regulated Product(s)
		 DrugsElectronic Regulatory Submission and Review

          
                        eCTD Resources
          CDER Data Standards Program
          Data Standards in the Drug Lifecycle
          Electronic Common Technical Document (eCTD)
          Electronic Regulatory Submissions and Review Helpful Links
          Electronic Submissions Presentations
          Study Data for Submission to CDER


                        Data Standards Manual (monographs)
 
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