Notice 3/23/2020
NDA to BLA Transition Instruction to Industry
On March 23, 2020, the Biologics Price Competition and Innovation Act of 2009 required that an approved application for a “biological product” be deemed to be a license for the biological product. We are providing the additional instructions below to facilitate the initial eCTD submissions to such deemed BLAs on or after March 23, 2020.
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.dtd
http://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.”
